The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Brow Ptosis, Facial Scarring
In brief
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.
Key facts
- Study ID
- NCT03219580
- Run by
- Eyelid and Facial Consultants
- People needed
- 50
- Starts
- 2017-05-20
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2018-07-26
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)
You may not qualify if…
- 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
Where it is running
- Leonard J. Chabert Medical Center — Houma, Louisiana, United States
- Eyelid and Facial Consultants — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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