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Injection of 5-fluorouracil in treatment of keloids

Comparison of intralesional 5-fluorouracil with intralesional triamcinolone acetonide in the treatment of keloids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024219
Enrollment
30
Registered
2020-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L918- Other hypertrophic disorders of the skin

Interventions

Intervention1: Intralesional injection of 5-fluorouracil: Keloid scars will receive intralesional 5-FU, 0.2 ml/sq cm (10 mg/sq cm) (50mg/ml ampoule) with a maximum dose of 100 mg in an adult. A 2 ml d

Sponsors

Lok Nayak Hospital and associated MAMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients between 18-60 years, having keloid scars with maximum scar size of 20 cm2. If one patient has multiple scars, no more than two scar sites will be included in the study.

Exclusion criteria

Exclusion criteria: -Pregnancy and lactation -Patients with co-morbidities like diabetes, hypertension, coronary artery disease, chronic liver disease. -Any patient with history of treatment with intralesional steroid injection in previous six months for the same site. -Infected keloids

Design outcomes

Primary

MeasureTime frame
Clinical scar assessment based on Vancouver Scar Scale (VSS) that scores the scars on four parameters namely pigmentation, vascularity, pliability and height.Timepoint: At the end of each injection session and till last follow up scheduled at monthly intervals for 2 months.

Secondary

MeasureTime frame
Pain assessment as per Visual Analogue Scale (VAS) Adverse effects such as ulceration, telengectasias, skin atrophy, infection, pigmentary changes, any other. Timepoint: At the end of each injection session and till last follow up scheduled at monthly intervals for 2 months.

Countries

India

Contacts

Public ContactDr Vishwadeep

Lok Nayak Hospital

drpsacademics@gmail.com09873617581

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026