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Completed

NCT Number: NCT01023841

Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

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Key information

Conditions

Eyelash Hypotrichosis Alopecia Alopecia Areata Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
  • Children who have minimal to moderate inadequate eyelashes due to alopecia areata
  • Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion criteria

  • Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
  • Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
  • Use of over the counter eyelash growth products within 6 months.
  • Use of prescription eyelash growth products (eg, Latisse®)
  • Any eye condition that would prevent required ophthalmology exams

Treatment and study plan

bimatoprost ophthalmic solution 0.03%

Drug

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Other names: LATISSE®

vehicle sterile solution

Drug

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Primary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: 5 Months

    An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

  2. Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score

    Time frame: Baseline, Month 4

    The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.

Secondary outcomes

  1. Change From Baseline Upper 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 Upper 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 Upper Eyelash Darkness as Measured by DIA

    Time frame: Baseline, Month 4

    Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2009
Registry last updated
Apr 17, 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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