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

Hypotrichosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958035
• Other study ID #: 192024-039
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2009
• Last updated: November 30, 2011
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotrichosis

Intervention

Drug:
• bimatoprost ophthalmic 0.03% solution
Apply one drop of study medication along the upper eyelid margin once daily in the evening
• vehicle sterile solution (placebo)
Apply one drop of study medication along the upper eyelid margin once daily in the evening

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No