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Intralesional Triamcinolone Acetonide and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars

NCT04812626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-04-07

No results posted yet for this study

Summary

Summary: Keloids and hypertrophic scars are benign fibrous growth, differing mainly by overgrowth beyond the initial defect in keloid whereas hypertrophic scar is confined to initial lesion and tends to regress over the years. Keloids and hypertrophic scars mainly lead to cosmetic disfigurement and functional deformity depending on site of involvement, in addition to symptoms like pain and pruritus, encountered occasionally. These sometimes might lead to psychological impact too. Different treatment options for keloids and hypertrophic scar are silicone gel/ sheets, corticosteroids, cryotherapy, lasers, antineoplastic agents (5-FU, mitomycin-C), surgical excision and immunomodulators (imiquimod) used either as monotherapy or combination therapy. Different studies involving combination of TAC and 5-FU have been done so far which shows better treatment outcome in terms of efficacy and safety. In a recent meta-analysis published in 2017 concluded that combination therapy of 5-FU + TAC offers better outcome than TAC alone, however recommended additional randomized, controlled, large-sample, high quality trial are needed for a more objective analysis of the treatment efficacy and to assess the adverse reaction associated. We are conducting this study the objective to compare the efficacy and safety profile of intralesional triamcinolone acetonide alone and its combination with 5-FU of the treatment of keloids and hypertrophic scars. This study may help in finding out the optimum treatment option in keloid and hypertrophic scar with minimal side effects in our clinical practice.

Conditions

  • Scar Keloid

Interventions

DRUG

5-Fluorouracil

Group A: 1ml of 40mg/ml triamcinolone acetonide will be mixed with 1ml of normal saline Group B:1 ml of 40 mg/ml triamcinolone acetonide will be mixed with 1ml of 50 mg/ml FU Five units (0.125ml) of the mixture TAC 40mg/ml and 5-FU 50mg/ml (1:1) i.e. 2.5mg TAC and 3.125mg of 5-FU or TAC 40mg/ml and 2%xylocaine (1:1) i.e. 2.5mg of TAC will be given intralesional with the help of 1ml insulin syringe of 40units, that covers an area of about 0.5X0.5 cm2 of scar, thus, a scar of 1 cm2 will require 4 injections to cover the whole lesion. Each extra area of 0.5x0.5cm2 will be given 5 units of injection of above mixture of drugs. For the larger lesions, dose can be increased but no more than 2ml in each group. Injection will be given at 2 weeks interval for total of 6 sessions (at 0,2, 4, 6,8,10 weeks) Post treatment follow up: at 12 weeks.

Sponsors & Collaborators

  • Nepal Health Research Council

    collaborator OTHER_GOV

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Principal Investigators

  • Ripala Acharya, MBBS · B.P. Koirala Institute of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2021-08-14
Completion
2021-09-14

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812626 on ClinicalTrials.gov