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

NCT03219580 | Unknown Phase 3 FDA Drug

• 1 other identifier: LSUIRB#9586
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Brow Ptosis; Facial Scarring

Outcome Measures

Primary Outcomes (4)

• Overall appearance

  Patient and physician impression of overall appearance of the direct brow incision scar

  1 year

• 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

• 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

• 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 Outcomes (1)

• Incidence of side effects

  1 year

Study Arms (2)

5-Fluorouracil Active Treatment Arm

ACTIVE COMPARATOR

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.

Drug: 5-Fluorouracil

Placebo Arm

PLACEBO COMPARATOR

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.

Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

5-Fluorouracil DRUG

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

5-Fluorouracil Active Treatment Arm

Normal Saline Flush, 0.9% Injectable Solution DRUG

0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eyelid and Facial Consultants: lead
• Ochsner Health System: collaborator

Study Sites (2)

Leonard J. Chabert Medical Center

Houma, Louisiana, 70363, United States

Location

Eyelid and Facial Consultants

New Orleans, Louisiana, 70115, United States

Location

Related Publications (11)

• 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. doi: 10.1124/mol.64.3.707.

  PMID: 12920208 BACKGROUND

• 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.

  PMID: 25025385 BACKGROUND

• 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.

  PMID: 27119465 BACKGROUND

• Gupta S, Kalra A. Efficacy and safety of intralesional 5-fluorouracil in the treatment of keloids. Dermatology. 2002;204(2):130-2. doi: 10.1159/000051830.

  PMID: 11937738 BACKGROUND

• 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. doi: 10.1016/j.jaad.2004.09.018.

  PMID: 15761426 BACKGROUND

• 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.

  PMID: 27784253 BACKGROUND

• 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.

  PMID: 25823177 BACKGROUND

• 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.

  PMID: 19018794 BACKGROUND

• 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.

  PMID: 23810214 BACKGROUND

• 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.

  PMID: 25950503 BACKGROUND

• 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.

  PMID: 26236447 BACKGROUND

MeSH Terms

Interventions

Fluorouracil

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adham B. al Hariri, M.D.

  Eyelid and Facial Consultants New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both patients and physicians are blinded in this study. The study log is maintained by a study nurse who maintains the log of which side is randomized to placebo and active treatment arm respectively. The study nurse is also responsible for preparing the 2 arms in identical syringes, ensuring each arm is injected into its respective laterality
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who undergo bilateral direct brow ptosis repair will be randomized to have one brow as the placebo arm and one arm as the active treatment arm. This original randomization will be maintained throughout the study.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: May 20, 2017
• Primary Completion: April 30, 2020
• Study Completion: August 1, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)