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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01023841
First Posted: December 2, 2009
Last Update Posted: September 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Eyelash Hypotrichosis Alopecia Areata Drug: bimatoprost ophthalmic solution 0.03% Drug: Vehicle Sterile Solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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).

  • 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).

  • 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).


Enrollment: 71
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bimatoprost ophthalmic solution 0.03%
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.
Drug: bimatoprost ophthalmic solution 0.03%
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 Name: LATISSE®
Placebo Comparator: Vehicle Sterile Solution
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.
Drug: Vehicle Sterile Solution
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01023841


Locations
United States, California
Newport Beach, California, United States
Brazil
São Paulo, Brazil
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01023841     History of Changes
Other Study ID Numbers: 192024-040
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: July 9, 2013
Results First Posted: September 13, 2013
Last Update Posted: September 13, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents