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).

Completed

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Key information

Conditions

Hypotrichosis Hair Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

bimatoprost ophthalmic 0.03% solution

Drug

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Other names: LATISSE®

vehicle sterile solution (placebo)

Drug

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Primary outcomes

Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 13, 2009
Registry last updated: Jan 5, 2012

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.

Published trials that share one or more normalized conditions with this study.

Completed