Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

Allergan

Status and phase

Completed

Phase 3

Conditions

Eyelash Hypotrichosis

Treatments

Drug: bimatoprost solution 0.03%

Drug: bimatoprost vehicle solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01391286

192024-067

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Enrollment

36 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have inadequate eyelashes due to chemotherapy treatment
Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss

Exclusion criteria

Any disease/infection/abnormality of the eye or area around the eye
Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy