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The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial uses 5-Fluorouracil injections to improve healing and reduce scarring after eyebrow surgery. It targets patients who have had surgery to correct drooping eyebrows. The medicine works by helping the skin heal better and reducing the formation of thick scars. 5-Fluorouracil (5-FU) has been used effectively for the treatment of hypertrophic scars and to manage excess scar tissue in various surgical contexts.
Eligible Conditions
- Drooping Eyebrows
- Facial Scarring
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall appearance
Scar is flush with eyebrow
Scar roughness/tough to touch
+1 moreSecondary study objectives
Incidence of side effects
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
96 Previous Clinical Trials
91,850 Total Patients Enrolled
Eyelid and Facial ConsultantsLead Sponsor
Adham B. al Hariri, M.D.Principal InvestigatorEyelid and Facial Consultants New Orleans