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

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ClinicalTrials.gov Identifier: NCT01391286
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Eyelash Hypotrichosis Drug: bimatoprost solution 0.03% Drug: bimatoprost vehicle solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: 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.
Other Name: LATISSE®
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.
Drug: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391286


Locations
Japan
Chiba, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01391286     History of Changes
Other Study ID Numbers: 192024-067
First Posted: July 12, 2011    Key Record Dates
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Pharmaceutical Solutions
Bimatoprost
Antihypertensive Agents