The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
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|ClinicalTrials.gov Identifier: NCT03219580|
Recruitment Status : Unknown
Verified July 2018 by Eyelid and Facial Consultants.
Recruitment status was: Enrolling by invitation
First Posted : July 17, 2017
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brow Ptosis Facial Scarring||Drug: 5-Fluorouracil Drug: Normal Saline Flush, 0.9% Injectable Solution||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both patients and physicians are blinded in this study. The study log is maintained by a study nurse who maintains the log of which side is randomized to placebo and active treatment arm respectively. The study nurse is also responsible for preparing the 2 arms in identical syringes, ensuring each arm is injected into its respective laterality|
|Official Title:||The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair|
|Actual Study Start Date :||May 20, 2017|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Active Comparator: 5-Fluorouracil Active Treatment Arm
A patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The active treatment arm brow will be injected with 0.05ml of 5-Fluorouracil 50mg/ml in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections.
50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions
Placebo Comparator: Placebo Arm
A patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The placebo arm brow will be injected with 0.05ml of 0.9% Normal Saline in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections.
Drug: Normal Saline Flush, 0.9% Injectable Solution
0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions
- Overall appearance [ Time Frame: 1 year ]Patient and physician impression of overall appearance of the direct brow incision scar
- Skin tone match [ Time Frame: 1 year ]Patient and physician impression of how close the direct brow incision scar matches the patient's natural skin tone/color
- Scar roughness/tough to touch [ Time Frame: 1 year ]Patient and physician impression as to the degree of rough to the touch (ie fibrosis) is present in the direct brow incision scar
- Scar is flush with eyebrow [ Time Frame: 1 year ]Patient and physician impressions as to degree that direct brow incision scar is flush with skin of the brow
- Incidence of side effects [ Time Frame: 1 year ]Any incidence of any side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219580
|United States, Louisiana|
|Leonard J. Chabert Medical Center|
|Houma, Louisiana, United States, 70363|
|Eyelid and Facial Consultants|
|New Orleans, Louisiana, United States, 70115|
|Principal Investigator:||Adham B. al Hariri, M.D.||Eyelid and Facial Consultants New Orleans|