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

• Status: Recruiting
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: B.P. Koirala Institute of Health Sciences
• Collaborator: Nepal Health Research Council
• Treatments: Fluorouracil; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Patient with clinically diagnosed keloid or hypertrophic scar 2. Size of scar 1cm in length or more 4. Informed consent given

Exclusion Criteria:

1. Under treatment of keloids or hypertrophic scar in past 6 months

2. Patient with renal disease

3. Patient with liver disease

4. History of Hypersensitivity to 5-fluorouracil or triamcinolone acetonide

4. Immunosuppressed conditions: HIV, Immunosuppressive therapy, Uncontrolled diabetes 5. Pregnant or lactating women or patient planning for pregnancy 6. Open wound in the scar 7. Atrophic scar 8. Patients suffering from chronic infectious conditions like Tuberculosis 9. Patients with low WBC count