A clinical trial to study the effects of drug named Triamcinolone alone or combination of Triamcinolone and 5- Fluorouracil in patients with Keloid or hypertrophic scars

Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: randomised control trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000546853

Enrollment

108

Registered

2012-05-23

Start date

2012-05-30

Completion date

2013-03-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The objective of study is to establish safety and efficacy of 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars. We included a total of 120 patients of more than 12 years of age with no history of chronic renal or liver disease. They were divided into group A, who received intralesional triamcinolone acetonide (TAC) alone and group B who received combination of 5-FU and TAC. Total of 8 injections were given at weekly interval. Patients were assessed at the beginning, at 4th and 8th week of treatment and then 4 weeks after the treatment for mean reduction in scar height, efficacy (more than 50% reduction in initial scar height) and complications of both treatments.

Interventions

Group A, all patients will be treated with once weekly intralesional triamcinolone (TAC)10mg (0.25ml of 40mg/ml TAC diluted with 0.75ml injectable normal saline) for a total of 8 sessions. Group B patients will be treated once weekly with intralesional injection of TAC 4 mg (0.1 ml of 40 mg/ml TAC) mixed with 5-fluorouracil (5-FU) 45 mg (0.9 ml of 50 mg/ml 5-FU) for a total of eight sessions

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Age above 12 years/either sex Keloid or hypertrophic scar more than 10mm in size measured clinically

Exclusion criteria

History of treatment for scar taken in last 6 months History of chronic renal failure or serum creatinine > 1.2mg/dl. Abnormalities in liver function tests (ALT > 35 IU) and blood counts (WBC < 4 or > 11 thousand cells) on laboratory investigations. Pregnant/lactating women or planning pregnancy

Outcome results