Clinical trial NCT03219580: The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
Official title: The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brow Ptosis
Facial Scarring
Lead sponsor: Eyelid and Facial Consultants
Sponsor class: OTHER
Collaborators: name: Ochsner Health System
First posted: 2017-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who undergo bilateral direct brow ptosis repair will be randomized to have one brow as the placebo arm and one arm as the active treatment arm. This original randomization will be maintained throughout the study.
Primary purpose: PREVENTION

Brief summary: 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 brow 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. The researchers 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.

Detailed description: 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 the nurse 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 each 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.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)

Exclusion Criteria:

* Known prior knowledge of the study's existence
* History of hypertrophic scarring
* Prior brow surgery, prior incisions or trauma to the forehead, brow or peri-ocular area in the past
* Patients who are decisionally or mentally impaired as they will be required to fill out the supplied survey and have the capacity for consent for the treatment
* Patients with any disease which may affect the brow (e.g. Myasthenia Gravis)
* Actively being treated for malignancy
* Uncontrolled autoimmune diseases with skin involvement

Primary outcomes:
measure: Overall appearance
timeFrame: 1 year
measure: Skin tone match
timeFrame: 1 year
measure: Scar roughness/tough to touch
timeFrame: 1 year
measure: Scar is flush with eyebrow
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of side effects
timeFrame: 1 year
Other outcomes:
Locations:
city: Houma
country: United States
facility: Leonard J. Chabert Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Eyelid and Facial Consultants
state: Louisiana
Study officials:
affiliation: Eyelid and Facial Consultants New Orleans
name: Adham B. al Hariri, M.D.
role: PRINCIPAL_INVESTIGATOR
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