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

Brow Ptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03219580
• Other study ID #: LSUIRB#9586
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: May 20, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2018
• Source: Eyelid and Facial Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this double-blinded (physician and patient) randomized controlled clinical trial, the patient's left and right brows are randomized to either the placebo or treatment arm of the study and maintain this designation for the entirety of the study. This randomization is performed and recorded by the study nurse in the physician's office. This study nurse also will be responsible for preparing the placebo 0.9% Normal Saline (0.9%NS) and the 50mg/mL 5-Fluorouracil (5-FU). Both placebo and 5-FU are placed into identical syringes with 30 gauge needles, both materials are identical in color and clarity, making it impossible for physician or patient to correctly identify which injection is which without a label. Only the study nurse will be aware of which injection is which, and the nurse will ensure that the correct injection is placed into the correct brow at each visit via the study log that the nurse maintains.

A patient who has undergone bilateral direct brow ptosis repair who has agreed to participate in the study will first return for the post-operative day 10 visit where sutures are removed from the brow incisions. The patient returns on post-operative week three for their first injections, the details of which are below:

Starting on post-operative week three, the patient will receive 0.05mL aliquots of each injection (0.9%NS and 5-FU) sub-dermally into the brow incision spread out evenly over the brow, totaling 0.3-0.6 mL of each injection over each respective brow. Photos of the patient's brows will be taken, and then both the physician and patient will fill out a survey recording their impressions, the contents of which are listed in subsequent sections of this protocol. This same procedure will be repeated every three weeks for a total of up to four rounds of injections, thus the final round of injections will be given on post-operative week twelve. At each of these post-operative visits, incidence of any side effects is recorded, and if an unacceptably high rate of side effects occurs, the study will be precociously terminated.

At post-operative week fifteen, the blind is broken, and again photos are taken and physician and patient impressions are recorded via survey. After the blind is broken, if desired, the patient can opt to undergo a similar series of injections on the placebo arm of 5-FU.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 1, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Brow Ptosis
• Facial Scarring
• Prolapse

Intervention

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

Locations

Country	Name	City	State
United States	Leonard J. Chabert Medical Center	Houma	Louisiana
United States	Eyelid and Facial Consultants	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Eyelid and Facial Consultants	Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (11)

Darougheh A, Asilian A, Shariati F. Intralesional triamcinolone alone or in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. Clin Exp Dermatol. 2009 Mar;34(2):219-23. doi: 10.1111/j.1365-2230.2007.02631.x. Epub 2008 Nov 6. — View Citation

Fang QQ, Chen CY, Zhang MX, Huang CL, Wang XW, Xu JH, Wu LH, Zhang LY, Tan WQ. The Effectiveness of Topical Anti-scarring Agents and a Novel Combined Process on Cutaneous Scar Management. Curr Pharm Des. 2017;23(15):2268-2275. doi: 10.2174/1381612822666161025144434. Review. — View Citation

Gupta S, Kalra A. Efficacy and safety of intralesional 5-fluorouracil in the treatment of keloids. Dermatology. 2002;204(2):130-2. — View Citation

Huang L, Cai YJ, Lung I, Leung BC, Burd A. A study of the combination of triamcinolone and 5-fluorouracil in modulating keloid fibroblasts in vitro. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):e251-9. doi: 10.1016/j.bjps.2013.06.004. Epub 2013 Jun 28. — View Citation

Jones CD, Guiot L, Samy M, Gorman M, Tehrani H. The Use of Chemotherapeutics for the Treatment of Keloid Scars. Dermatol Reports. 2015 May 21;7(2):5880. doi: 10.4081/dr.2015.5880. eCollection 2015 May 21. Review. — View Citation

Khan MA, Bashir MM, Khan FA. Intralesional triamcinolone alone and in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. J Pak Med Assoc. 2014 Sep;64(9):1003-7. — View Citation

Kontochristopoulos G, Stefanaki C, Panagiotopoulos A, Stefanaki K, Argyrakos T, Petridis A, Katsambas A. Intralesional 5-fluorouracil in the treatment of keloids: an open clinical and histopathologic study. J Am Acad Dermatol. 2005 Mar;52(3 Pt 1):474-9. — View Citation

Poetschke J, Gauglitz GG. Current options for the treatment of pathological scarring. J Dtsch Dermatol Ges. 2016 May;14(5):467-77. doi: 10.1111/ddg.13027. Review. — View Citation

Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502. — View Citation

Wendling J, Marchand A, Mauviel A, Verrecchia F. 5-fluorouracil blocks transforming growth factor-beta-induced alpha 2 type I collagen gene (COL1A2) expression in human fibroblasts via c-Jun NH2-terminal kinase/activator protein-1 activation. Mol Pharmacol. 2003 Sep;64(3):707-13. — View Citation

Yoo DB, Azizzadeh B, Massry GG. Injectable 5-FU with or without added steroid in periorbital skin grafting: initial observations. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):122-6. doi: 10.1097/IOP.0000000000000214. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall appearance	Patient and physician impression of overall appearance of the direct brow incision scar	1 year
Primary	Skin tone match	Patient and physician impression of how close the direct brow incision scar matches the patient's natural skin tone/color	1 year
Primary	Scar roughness/tough to touch	Patient and physician impression as to the degree of rough to the touch (ie fibrosis) is present in the direct brow incision scar	1 year
Primary	Scar is flush with eyebrow	Patient and physician impressions as to degree that direct brow incision scar is flush with skin of the brow	1 year
Secondary	Incidence of side effects	Any incidence of any side effects	1 year