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

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).

Study Overview

• Status: Completed
• Conditions: Hypotrichosis
• Intervention / Treatment: Drug: bimatoprost ophthalmic 0.03% solution; Drug: vehicle sterile solution (placebo)

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LATISSE®; bimatoprost ophthalmic 0.03% solution	Drug: bimatoprost ophthalmic 0.03% solution; Apply one drop of study medication along the upper eyelid margin once daily in the evening; Other Names: LATISSE®
PLACEBO_COMPARATOR: Placebo; vehicle sterile solution	Drug: vehicle sterile solution (placebo); Apply one drop of study medication along the upper eyelid margin once daily in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 4

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (ESTIMATE): August 13, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypotrichosis; Antihypertensive Agents; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: 192024-039