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

Maharajgunj Medical Campus41 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Keloids

Interventions

Intralesional Triamcinolone 5 mg/mlDRUG

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.

Intralesional 5-fluorouracilDRUG

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Maharajgunj Medical Campus, Institute of Medicine

Kathmandu, Nepal

Outcomes

Primary Outcomes

Scar Height

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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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