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NCT Number: NCT01391286

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

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.

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Key information

Conditions

Eyelash Hypotrichosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bimatoprost solution 0.03%

Drug

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

Other names: LATISSE®

bimatoprost vehicle solution

Drug

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 12, 2011
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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