The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
Sponsors
Source
Eyelid and Facial Consultants
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
Is Us Export
No
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 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.
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.
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 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.
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.
Overall Status
Enrolling by invitation
Start Date
2017-05-20
Completion Date
2018-08-01
Primary Completion Date
2018-04-30
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Overall appearance |
1 year |
Skin tone match |
1 year |
Scar roughness/tough to touch |
1 year |
Scar is flush with eyebrow |
1 year |
Secondary Outcome
Measure |
Time Frame |
Incidence of side effects |
1 year |
Enrollment
50
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions
Arm Group Label
5-Fluorouracil Active Treatment Arm
Intervention Type
Drug
Intervention Name
Description
0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions
Arm Group Label
Placebo Arm
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
- 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
Gender
All
Minimum Age
40 Years
Maximum Age
90 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Adham B. al Hariri, M.D. |
Principal Investigator |
Eyelid and Facial Consultants New Orleans |
Location
Facility |
Leonard J. Chabert Medical Center Houma Louisiana 70363 United States |
Eyelid and Facial Consultants New Orleans Louisiana 70115 United States |
Location Countries
Country
United States
Verification Date
2017-07-01
Lastchanged Date
2017-07-13
Firstreceived Date
2017-07-13
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Fluorouracil
Arm Group
Arm Group Label
5-Fluorouracil Active Treatment Arm
Arm Group Type
Active Comparator
Description
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.
Arm Group Label
Placebo Arm
Arm Group Type
Placebo Comparator
Description
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.
Firstreceived Results Date
N/A
Reference
Citation
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Khan MA, Bashir MM, Khan FA. Intralesional triamcinolone alone and in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. J Pak Med Assoc. 2014 Sep;64(9):1003-7.
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PMID
26236447
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group 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.
Primary Purpose
Prevention
Masking
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
ClinicalTrials.gov processed this data on July 17, 2017
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.