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

Completed

• Conditions: Keloids
• Interventions: Drug: Intralesional Triamcinolone 5 mg/ml; Drug: Intralesional 5-fluorouracil

• Registration Number: NCT07034482
• Lead Sponsor: Maharajgunj Medical Campus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size	Intralesional Triamcinolone 5 mg/ml	-
Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size	Intralesional 5-fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Vancouver Scar Scale (VSS) Score	12 months	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)
Patient-Reported Pain Score	12 months	Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain)
Scar Height	12 months	Change in scar height measured in millimeters (mm) using a standardized caliper.
Patient-Reported Pruritus Score	12 months	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)
Patient-Reported Scar Appearance Score	12 months	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)

Trial Locations

Locations (1)

Maharajgunj Medical Campus, Institute of Medicine; 🇳🇵 Kathmandu, Nepal