Intralesional Triamcinolone Acetonide and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars
Status:
Recruiting
Trial end date:
2021-09-15
Target enrollment:
Participant gender:
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.