Efficacy and safety of intralesional triamcinolone acetonide alone and its combination with 5- fluorouracil in keloids and hypertrophic scars: Randomized, parallel group, and double blinded trial.

Abstract

Background: Treatment of keloids and hypertrophic scars is challenging. The current first-line treatment is a steroid which has high resistance and recurrence rate along with unacceptable adverse effects. Different studies involving the combination of TAC and 5-FU that have been done so far showed better treatment outcomes in terms of efficacy and safety.

Objective: The objective of this study was to compare the efficacy and safety of intralesional triamcinolone acetonide alone and its combination with 5-fluorouracil in patients with keloids and hypertrophic scars at 12 weeks follow-up.

Methods: In this randomized parallel group double-blinded clinical trial, we enroled 66 cases of keloids and hypertrophic scars randomly allocated into two treatment groups. Patients received an intralesional injection of triamcinolone acetonide (20 mg/mL) in Group A and an intralesional injection of a combination of triamcinolone acetonide (20 mg/mL) and 5-fluorouracil (25 mg/mL) in Group B for every 2 weeks until 10 weeks and the final evaluation was done at 12 weeks follow-up.

Results: There was a reduction in all the parameters at every follow-up visit in both groups. The ≥50% reduction in height, reduction in the VSS and POSAS scores, and good to excellent subjective improvement reported by both the patients and the observer were significantly greater in the combination group compared to TAC alone group. The response rate was faster and complications were lesser in the combination group as compared to TAC alone group.

Limitation: Single-centred, no long-term follow-up, and recurrence could not be assessed.

Conclusion: TAC alone and its combination with the 5-FU both were effective in keloids and hypertrophic scars. Yet, the TAC and 5-FU combination treatment was more efficacious with a faster response rate and safer than the TAC alone treatment.