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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01023841
First received: November 30, 2009
Last updated: July 9, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01023841     History of Changes
Other Study ID Numbers: 192024-040
Study First Received: November 30, 2009
Results First Received: July 9, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ophthalmic Solutions
Pharmaceutical Solutions
Bimatoprost
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014