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

This study has been completed.
Information provided by (Responsible Party):
Allergan Identifier:
First received: August 11, 2009
Last updated: November 30, 2011
Last verified: November 2011
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).

Condition Intervention Phase
Hypotrichosis Drug: bimatoprost ophthalmic 0.03% solution Drug: vehicle sterile solution (placebo) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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).

Enrollment: 89
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00958035

United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan Identifier: NCT00958035     History of Changes
Other Study ID Numbers: 192024-039
Study First Received: August 11, 2009
Results First Received: November 30, 2011
Last Updated: November 30, 2011

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases
Pharmaceutical Solutions
Antihypertensive Agents processed this record on July 27, 2017