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

• Status: Completed
• Trial end date: 2012-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Bimatoprost; Pharmaceutical Solutions

Criteria

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