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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
History of Changes
  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:

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost
U.S. FDA Resources

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
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
Bimatoprost
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013