Post-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of Keloids

NCT04710719 | Completed DMC

• 1 other identifier: Keloid_5FU/TAC
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

There have been many modalities utilized in the treatment of keloids of the head and neck, however none have been universally successful. The most widely utilized non-surgical intervention is primary intralesional injection with triamcinolone (TAC) which inhibits the proliferation of fibroblasts, inhibits collagen synthesis, and increases collagenase production, or fluorouracil (5-FU), a potent inhibitor of fibroblast proliferation. Despite the abundance of studies evaluating primary intralesional injection for keloids, there are limited studies available regarding the efficacy of primary surgical excision followed by adjuvant intralesional injection. The proposed study herein would serve to improve the level of evidence and to establish the safety and efficacy of combined intralesional TAC+5FU for keloids following surgical excision.

Conditions

Keloid; Keloid Scar Following Surgery

Outcome Measures

Primary Outcomes (1)

• Keloid Recurrence by visual assessment meaning either there is or is not a keloid physically present (determined by number of keloids observed and rate of recurrence after treatment)

  Treatment effective if no keloid recurrence is visible by 12 months post treatment

  12 months

Secondary Outcomes (1)

• Symptomatology-assessed by Patient and Observer Scar Assessment Scale

  3 months

Study Arms (2)

TAC only

ACTIVE COMPARATOR

Participants will be treated with adjuvant intralesional TAC 40mg/mL 7-10 days post-op and then every 4 weeks for a total of 3 injections. Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS).

Drug: Triamcinolone Injection

TAC + 5FU

ACTIVE COMPARATOR

Participants will be treated with adjuvant intralesional TAC and 5FU at a dose of 0.1mg TAC for every 0.9mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections. Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS).

Drug: Triamcinolone Injection and 5-fluorouracil injection

Interventions

Triamcinolone Injection DRUG

Post surgical injection at site of keloid with TAC for 3 injections

Also known as: TAC

TAC only

Triamcinolone Injection and 5-fluorouracil injection DRUG

Post surgical injection at site of keloid with TAC and 5FU for 3 injections

Also known as: TAC + 5FU

TAC + 5FU

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of any age
• Subjects with at least one keloid of any size located in the head and neck region

You may not qualify if:

• subjects with comorbidities prohibiting local injection of either TAC or 5FU including pregnancy, lactation, or planning pregnancy.

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (6)

• Ren Y, Zhou X, Wei Z, Lin W, Fan B, Feng S. Efficacy and safety of triamcinolone acetonide alone and in combination with 5-fluorouracil for treating hypertrophic scars and keloids: a systematic review and meta-analysis. Int Wound J. 2017 Jun;14(3):480-487. doi: 10.1111/iwj.12629. Epub 2016 Jul 18.

  PMID: 27427423 BACKGROUND

• Khalid FA, Mehrose MY, Saleem M, Yousaf MA, Mujahid AM, Rehman SU, Ahmad S, Tarar MN. Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: Randomised control trial. Burns. 2019 Feb;45(1):69-75. doi: 10.1016/j.burns.2018.08.011. Epub 2018 Oct 16.

  PMID: 30340861 BACKGROUND

• Al-Attar A, Mess S, Thomassen JM, Kauffman CL, Davison SP. Keloid pathogenesis and treatment. Plast Reconstr Surg. 2006 Jan;117(1):286-300. doi: 10.1097/01.prs.0000195073.73580.46.

  PMID: 16404281 BACKGROUND

• Davison SP, Dayan JH, Clemens MW, Sonni S, Wang A, Crane A. Efficacy of intralesional 5-fluorouracil and triamcinolone in the treatment of keloids. Aesthet Surg J. 2009 Jan-Feb;29(1):40-6. doi: 10.1016/j.asj.2008.11.006.

  PMID: 19233005 BACKGROUND

• Wu XL, Gao Z, Song N, Liu W. [Clinical study of auricular keloid treatment with both surgical excision and intralesional injection of low-dose 5-fluorouracil and corticosteroids]. Zhonghua Yi Xue Za Zhi. 2009 Apr 28;89(16):1102-5. Chinese.

  PMID: 19595138 BACKGROUND

• Nicholas RS, Falvey H, Lemonas P, Damodaran G, Ghannem A, Selim F, Navsaria H, Myers S. Patient-related keloid scar assessment and outcome measures. Plast Reconstr Surg. 2012 Mar;129(3):648-656. doi: 10.1097/PRS.0b013e3182402c51.

  PMID: 22373972 BACKGROUND

MeSH Terms

Conditions

Keloid

Interventions

Triamcinolone; Fluorouracil

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Justin Sowder, MD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware of which injection they will be receiving in follow up treatment for their keloid (TAC alone or TAC/5FU)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 cohort arms, single blinded; 1=TAC alone, 2=TAC+5FU

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: February 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)