Post-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of Keloids

July 21, 2022 updated by: Our Lady of the Lake Hospital

Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids

There have been many modalities utilized in the treatment of keloids of the head and neck, however none have been universally successful. The most widely utilized non-surgical intervention is primary intralesional injection with triamcinolone (TAC) which inhibits the proliferation of fibroblasts, inhibits collagen synthesis, and increases collagenase production, or fluorouracil (5-FU), a potent inhibitor of fibroblast proliferation. Despite the abundance of studies evaluating primary intralesional injection for keloids, there are limited studies available regarding the efficacy of primary surgical excision followed by adjuvant intralesional injection. The proposed study herein would serve to improve the level of evidence and to establish the safety and efficacy of combined intralesional TAC+5FU for keloids following surgical excision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single blinded, prospective randomized controlled trial of patients who elect for surgical treatment of keloids at the Center for Facial Plastic and Reconstructive Surgery at Our Lady of the Lake Regional Medical Center (OLOLRMC), a tertiary referral center affiliated with the Louisiana State University Health Sciences Center (LSUHSC) teaching system. Power analysis estimated approximately 134 patients total (67 per group) for 80% power to detect a difference at the 5% confidence level. This is based off of a prior group's study comparing primary intralesional injection with TAC vs TAC+5FU (no surgery). That study showed 39.2% recurrence with TAC vs 17.5% with TAC+5FU.

The patients enrolled in the study will be randomized to one of two arms: surgical excision+TAC or surgical excision+TAC+5FU. Randomization will be performed using a permuted block randomization algorithm (Ex. AABBABABABBABBAA, where A=TAC only group and B=TAC +5FU). All patients will undergo surgical excision of the keloid, either under general anesthesia in the operating room or local anesthesia in the clinic setting depending on patient age and preference. The goal of excision will be complete extra-lesional excision with primary closure. It will be noted if a patient requires intra-lesional excision or additional reconstructive techniques such as advancement flap, skin grafting, or allografting (i.e. Integra). Monofilament sutures will be used preferentially to prevent local inflammatory reaction which can precipitate keloid formation. In group 1 (surgical excision+TAC), all patients will be treated with adjuvant intralesional TAC 40mg/mL 7-10 days post-op and then every 4 weeks for a total of 3 injections. The triamcinolone vial will be obtained from pharmacy and drawn up by the physician prior to injection. In group 2 (surgical excision+TAC+5FU), all patients will be treated with adjuvant intralesional TAC and 5FU at a dose of 0.1mg TAC for every 0.9mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections. The mixture of TAC+5FU will be prepared by the pharmacy and delivered to the physician prior to injection. The goal volume of injection for both arms of the study will be 0.1cc per cm2 of scar excised, though any deviations from this and the rationale will be noted.

Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS) which has been proven as a reliable and valid method of assessing keloid scars (5). The observer portion of the survey to be completed by the study team assesses vascularity, pigmentation, thickness, pliability, and surface area of the lesion. The patient portion of the survey focuses on the overall cosmetic and functional sequela including pain, itching, color, stiffness, thickness, and irregularity. Patients will also be asked about any side effects experienced. Each portion of the POSAS will be blinded from the study team member and the participant until both have completed the survey at each visit, so that one set of answers will not bias the other. If a patient demonstrates signs of recurrence or return of symptoms, there will be the option for additional injections within the patient's originally designated study arm. However, if early analysis demonstrates the alternative study arm to have superior efficacy, there will be the option to continue injections with the alternative study arm injection.

Data collection will include demographic data such as age, gender, race, and Fitzpatrick skin type, as well as location of the keloid, etiology (trauma, post-surgical, etc.), and prior treatments if any. The size and thickness of each lesion, secondary defect size following adjacent tissue transfer, and amount of adjuvant medication injected during each adjuvant injection will be collected. Data analysis will include overall efficacy as well as stratification by variables such as the location of the lesion, size of the lesion, and prior treatment.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of any age
  • Subjects with at least one keloid of any size located in the head and neck region

Exclusion Criteria:

  • subjects with comorbidities prohibiting local injection of either TAC or 5FU including pregnancy, lactation, or planning pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAC only
Participants will be treated with adjuvant intralesional TAC 40mg/mL 7-10 days post-op and then every 4 weeks for a total of 3 injections. Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS).
Drug: Triamcinolone Injection
Post surgical injection at site of keloid with TAC for 3 injections
Other Names:
  • TAC
Active Comparator: TAC + 5FU
Participants will be treated with adjuvant intralesional TAC and 5FU at a dose of 0.1mg TAC for every 0.9mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections. Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS).
Drug: Triamcinolone Injection and 5-fluorouracil injection
Post surgical injection at site of keloid with TAC and 5FU for 3 injections
Other Names:
  • TAC + 5FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keloid Recurrence by visual assessment meaning either there is or is not a keloid physically present (determined by number of keloids observed and rate of recurrence after treatment)
Time Frame: 12 months
Treatment effective if no keloid recurrence is visible by 12 months post treatment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatology-assessed by Patient and Observer Scar Assessment Scale
Time Frame: 3 months
Effectiveness of treatment on symptoms (pruritus, pain, hyperpigmentation or other side effects) as determined by changes in the POSAS survey (1 being "not observed" to 10 being "present always" and also by visual assessment by the physician
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady of the Lake Hospital

Collaborators

Louisiana State University Health Sciences Center in New Orleans

Investigators

  • Principal Investigator: Justin Sowder, MD, Louisiana State University Health Sciences Center - New Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Keloid_5FU/TAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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