Eyelid and Facial Consultants

This is a double (physician and patient) blinded randomized controlled clinical trial in
which patients who have undergone bilateral direct brow ptosis repair undergo a trial in
which one of their brows is injected with placebo 0.9% Normal Saline and the contra-lateral
brow is injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal
injections. We aim to investigate whether injecting 5-Fluorouracil preemptively will not only
accelerate wound healing and decrease hypertrophic scar formation compared to placebo, but
also improve overall scar appearance in a safe manner.

In this double-blinded (physician and patient) randomized controlled clinical trial, the
patient's left and right brows are randomized to either the placebo or treatment arm of the
study and maintain this designation for the entirety of the study. This randomization is
performed and recorded by the study nurse in the physician's office. This study nurse also
will be responsible for preparing the placebo 0.9% Normal Saline (0.9%NS) and the 50mg/mL
5-Fluorouracil (5-FU). Both placebo and 5-FU are placed into identical syringes with 30 gauge
needles, both materials are identical in color and clarity, making it impossible for
physician or patient to correctly identify which injection is which without a label. Only the
study nurse will be aware of which injection is which, and he or she will ensure that the
correct injection is placed into the correct brow at each visit via the study log that the
nurse maintains.

A patient who has undergone bilateral direct brow ptosis repair who has agreed to participate
in the study will first return for the post-operative day 10 visit where sutures are removed
from the brow incisions. The patient returns on post-operative week three for their first
injections, the details of which are below:

Starting on post-operative week three, the patient will receive 0.05mL aliquots of each
injection (0.9%NS and 5-FU) sub-dermally into the brow incision spread out evenly over the
brow, totaling 0.3-0.6 mL of each injection over their respective brow. Photos of the
patient's brows will be taken, and then both the physician and patient will fill out a survey
recording their impressions, the contents of which are listed in subsequent sections of this
protocol. This same procedure will be repeated every three weeks for a total of up to four
rounds of injections, thus the final round of injections will be given on post-operative week
twelve. At each of these post-operative visits, incidence of any side effects is recorded,
and if an unacceptably high rate of side effects occurs, the study will be precociously
terminated.

At post-operative week fifteen, the blind is broken, and again photos are taken and physician
and patient impressions are recorded via survey. After the blind is broken, if desired, the
patient can opt to undergo a similar series of injections on the placebo arm of 5-FU.

Enrolling by invitation

2017-05-20

2018-08-01

2018-04-30

Phase 3

Interventional

50

 Brow Ptosis,  Facial Scarring

2017-07-01

2017-07-13

2017-07-13

No

 Prolapse

2

N/A

N/A