Efficacy of Topical Bimatoprost in Promoting Hair Growth in the Region of the Eyebrow and Eyelashes for Post-chemotherapy Patients Versus Normal Patients
OBJECTIVES:
Primary
- To assess the effectiveness of bimatoprost ophthalmic solution in expediting regrowth
of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer
and in increasing eyebrow growth in healthy participants with no known underlying
disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.
Secondary
- To assess the effectiveness of this treatment as assessed by patient self-report on a
scale of 0-4.
- To assess the psychological impact of this treatment as assessed by patient-completed
questionnaires.
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid
margins OR to eyebrow region once daily for 4 months in the absence of unacceptable
toxicity.
- Arm II: Patients apply topical placebo solution to base of upper eyelid margins OR to
eyebrow region once daily for 4 months in the absence of unacceptable toxicity.
Patients complete questionnaires at baseline and monthly for 5 months about changes in
eyebrows/eyelashes, side effects of treatment, and the psychological impact of treatment.
Photographs of eyebrows or eyelashes and surrounding skin are taken at baseline and monthly
for 5 months and reviewed by a physician and aesthetics expert.
After completion of study treatment, patients are followed up at 1 month.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Measuring regrowth of eyebrows and eyelashes by Bimatoprost Opthalmic solution
Efficacy of Bimatoprost Opthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.
every 30 days for 4 months
No
Jenny Kim, MD, PhD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
CDR0000657044
NCT00999557
September 2013
Name | Location |
---|---|
University of California Los Angeles | Los Angeles, California 90095-6951 |