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The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair

NCT03219580 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

  • Brow Ptosis
  • Facial Scarring

Interventions

DRUG

5-Fluorouracil

50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions

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

Sponsors & Collaborators

  • Ochsner Health System

    collaborator OTHER

  • Eyelid and Facial Consultants

    lead OTHER

Principal Investigators

  • Adham B. al Hariri, M.D. · Eyelid and Facial Consultants New Orleans

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-20
Primary Completion
2020-04-30
Completion
2020-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03219580 on ClinicalTrials.gov