← Back to Search

5-Fluorouracil Active Treatment Arm for Drooping Eyebrows

Phase 3
Waitlist Available
Led By Adham B. al Hariri, M.D.
Research Sponsored by Eyelid and Facial Consultants
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligible Conditions
  • Drooping Eyebrows
  • Facial Scarring

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall appearance
Scar is flush with eyebrow
Scar roughness/tough to touch
+1 more
Secondary outcome measures
Incidence of side effects

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 5-Fluorouracil Active Treatment ArmActive Control1 Intervention
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.
Group II: Placebo ArmPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ochsner Health SystemOTHER
93 Previous Clinical Trials
184,611 Total Patients Enrolled
Eyelid and Facial ConsultantsLead Sponsor
Adham B. al Hariri, M.D.Principal InvestigatorEyelid and Facial Consultants New Orleans

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
2017. "The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03219580.
All > Scar
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top