Hypotrichosis, Madarosis
Conditions
Brief summary
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.
Interventions
DRUGBimatoprost eyelash gel
Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 YO females * madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer * only breast cancer patients
Exclusion criteria
* inability to follow up, apply gel * active eye/eyelid infection or inflammatory process * cancer not related to breast cancer, healthy patients * males
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eyelash length | 6 months | eyelash ruler used to measure eyelash length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eyelash pigment | 6 mos | blinded grader used digital photos to grade degree of pigment on scale of 1-5 |
| eyelash thickness | 6 mos | blinded grader used digital photos to grade degree of thickness on scale of 1-5 |
| eyelash amount | 6 mos | blinded grader used digital photos to grade degree of amount by counting lashes |
| eyelash side effects | 6 mos | any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed |
Countries
United States
Outcome results
None listed