Efficacy and Safety of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Keloids and Hypertrophic Scars

NCT07034482 | Completed

• 1 other identifier: 54(6-11)E2.077/078
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Plethora of options is in practice: intralesional (IL) injections, silicon sheets, lasers, cryotherapy, radiotherapy and surgery. This study analysed the effect of combination therapy of IL 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) in keloids and HTS's.

Conditions

Keloids

Outcome Measures

Primary Outcomes (5)

• Scar Height

  Change in scar height measured in millimeters (mm) using a standardized caliper.

  12 months

• Vancouver Scar Scale (VSS) Score

  Change in scar severity based on the Vancouver Scar Scale, a validated tool assessing vascularity, pigmentation, pliability, and height. Scale Range: 0 (normal skin) to 13 (worst scarring)

  12 months

• Patient-Reported Pain Score

  Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain)

  12 months

• Patient-Reported Pruritus Score

  Self-reported itch severity related to the scar, measured using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no itch) to 10 (worst imaginable itch)

  12 months

• Patient-Reported Scar Appearance Score

  Self-reported perception of scar appearance using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no visible scar) to 10 (worst possible scar appearance)

  12 months

Study Arms (1)

Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size

Drug: Intralesional Triamcinolone 5 mg/ml; Drug: Intralesional 5-fluorouracil

Interventions

Intralesional Triamcinolone 5 mg/ml DRUG

Solution containing 5 mg TAC was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe.

Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size

Intralesional 5-fluorouracil DRUG

Solution containing 45 mg 5-FU was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe.

Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted in the Department of Plastic Surgery and Burns, Tribhuvan University Teaching Hospital, Kathmandu, Nepal, from September 2020 to September 2021. Eligible participants included patients presenting with keloids or hypertrophic scars who met the predefined inclusion and exclusion criteria.

You may qualify if:

• Patients aged 16 years or more, with keloids or hypertrophic scar more than 10 mm in size

You may not qualify if:

• Signs of systemic or local infection
• who underwent treatment for same scar in the past 6 months
• Renal failure or liver dysfunction or bone marrow suppression

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

Maharajgunj Medical Campus, Institute of Medicine

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

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

Study Officials

• Prajjwol Luitel

  Institute Of Medicine (IOM), Maharajgunj Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)