MedTrace Logo

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

NCT04710719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Keloid
  • Keloid Scar Following Surgery

Interventions

DRUG

Triamcinolone Injection

Post surgical injection at site of keloid with TAC for 3 injections

DRUG

Triamcinolone Injection and 5-fluorouracil injection

Post surgical injection at site of keloid with TAC and 5FU for 3 injections

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Our Lady of the Lake Hospital

    lead OTHER

Principal Investigators

  • Justin Sowder, MD · Louisiana State University Health Sciences Center - New Orleans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710719 on ClinicalTrials.gov