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.

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.

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

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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PMID

12920208


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PMID

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Citation

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.

PMID

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Citation

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PMID

19018794


Citation

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PMID

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Citation

Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.

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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

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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

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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.

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