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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00958035
First received: August 11, 2009
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00958035

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Pharmaceutical Solutions
Bimatoprost
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014