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Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Primary Purpose

Hypotrichosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bimatoprost ophthalmic 0.03% solution
vehicle sterile solution (placebo)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotrichosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • African American/ethnic black
  • Adults at least 18 years of age
  • Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

  • Subjects with uneven lashes or longer on one side than the other
  • Any eye disease or abnormality
  • Eye surgery
  • Severe hyperpigmentation around the eye
  • Eyelash implants
  • Eyelash extension application
  • Any use of eyelash growth products within 6 months
  • Any use of prescription eyelash growth products
  • Treatments that may affect hair growth
  • Requiring eye drop medications for glaucoma

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LATISSE®

Placebo

Arm Description

bimatoprost ophthalmic 0.03% solution

vehicle sterile solution

Outcomes

Primary Outcome Measures

Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).

Secondary Outcome Measures

Full Information

First Posted
August 11, 2009
Last Updated
November 30, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00958035
Brief Title
Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotrichosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LATISSE®
Arm Type
Experimental
Arm Description
bimatoprost ophthalmic 0.03% solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vehicle sterile solution
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic 0.03% solution
Other Intervention Name(s)
LATISSE®
Intervention Description
Apply one drop of study medication along the upper eyelid margin once daily in the evening
Intervention Type
Drug
Intervention Name(s)
vehicle sterile solution (placebo)
Intervention Description
Apply one drop of study medication along the upper eyelid margin once daily in the evening
Primary Outcome Measure Information:
Title
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Description
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
Time Frame
Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African American/ethnic black Adults at least 18 years of age Eyelash prominence assessment of minimal or moderate Exclusion Criteria: Subjects with uneven lashes or longer on one side than the other Any eye disease or abnormality Eye surgery Severe hyperpigmentation around the eye Eyelash implants Eyelash extension application Any use of eyelash growth products within 6 months Any use of prescription eyelash growth products Treatments that may affect hair growth Requiring eye drop medications for glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

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