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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 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE July 8, 2011
First Posted Date  ICMJE July 12, 2011
Results First Submitted Date  ICMJE May 21, 2013
Results First Posted Date  ICMJE July 9, 2013
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE July 1, 2011
Actual Primary Completion Date May 25, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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 Measures  ICMJE
 (submitted: July 8, 2011)
Change from Baseline in Overall Eyelash Prominence [ Time Frame: Baseline, Month 4 ]
Change History Complete list of historical versions of study NCT01391286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
  • 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 Measures  ICMJE
 (submitted: July 8, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eyelash Hypotrichosis
Intervention  ICMJE
  • 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®
  • Drug: bimatoprost vehicle solution
    One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: bimatoprost solution 0.03%
  • 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.
    Intervention: Drug: bimatoprost vehicle solution
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2012)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2011)
30
Actual Study Completion Date  ICMJE May 25, 2012
Actual Primary Completion Date May 25, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01391286
Other Study ID Numbers  ICMJE 192024-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP