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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eyelid and Facial Consultants
• Collaborator: Ochsner Health System
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)

Exclusion Criteria:

• Known prior knowledge of the study's existence

• History of hypertrophic scarring

• Prior brow surgery, prior incisions or trauma to the forehead, brow or peri-ocular area in the past

• Patients who are decisionally or mentally impaired as they will be required to fill out the supplied survey and have the capacity for consent for the treatment

• Patients with any disease which may affect the brow (e.g. Myasthenia Gravis)

• Actively being treated for malignancy

• Uncontrolled autoimmune diseases with skin involvement