Phase 4 N=89 Randomized Double-blind Treatment

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

Hypotrichosis

Bottom Line

View on ClinicalTrials.gov: NCT00958035 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Jan 2012

Primary outcome: Primary: Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 — 69.6; 48.8 Percentage of Patients

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: bimatoprost ophthalmic 0.03% solution (Drug); vehicle sterile solution (placebo) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4	69.6; 48.8	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00958035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.