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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
Sponsor:
Collaborator:
Ochsner Health System
Information provided by (Responsible Party):
Eyelid and Facial Consultants

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.

Condition or disease Intervention/treatment Phase
Brow Ptosis Facial Scarring Drug: 5-Fluorouracil Drug: Normal Saline Flush, 0.9% Injectable Solution Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.
Drug: 5-Fluorouracil
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




Primary Outcome Measures :
  1. Overall appearance [ Time Frame: 1 year ]
    Patient and physician impression of overall appearance of the direct brow incision scar

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Incidence of side effects [ Time Frame: 1 year ]
    Any incidence of any side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Louisiana
Leonard J. Chabert Medical Center
Houma, Louisiana, United States, 70363
Eyelid and Facial Consultants
New Orleans, Louisiana, United States, 70115
Sponsors and Collaborators
Eyelid and Facial Consultants
Ochsner Health System
Investigators
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Principal Investigator: Adham B. al Hariri, M.D. Eyelid and Facial Consultants New Orleans
Publications:

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Responsible Party: Eyelid and Facial Consultants
ClinicalTrials.gov Identifier: NCT03219580    
Other Study ID Numbers: LSUIRB#9586
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs