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Completed

NCT Number: NCT07034482

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maharajgunj Medical Campus, Institute of Medicine

Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Scar Height

    Time frame: 12 months

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

  2. Vancouver Scar Scale (VSS) Score

    Time frame: 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)

  3. Patient-Reported Pain Score

    Time frame: 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)

  4. Patient-Reported Pruritus Score

    Time frame: 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)

  5. Patient-Reported Scar Appearance Score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Maharajgunj Medical Campus

Other

Registry information

Official study title

Efficacy and Safety of Combination Therapy of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Treatment of Keloids and Hypertrophic Scars: A Prospective Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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