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

Burns. 2019 Feb;45(1):69-75. doi: 10.1016/j.burns.2018.08.011. Epub 2018 Oct 16.


The treatment of keloid and hypertrophic scar is challenging with no universally accepted mode for permanent ablation. Conventional therapies yield unpredictable results, significant complications and require elaborate hardware.

Objective: The objective was to establish the safety and efficacy of intralesional 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars.

Study design: Randomized controlled trial (RCT).

Place and duration: It was conducted at the Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Lahore, Pakistan from May 2012 to March 2013.

Subjects and methods: We included 120 patients divided in two groups. The group A patients received intralesional triamcinolone acetonide (TAC) and the group B patients received both 5-FU and TAC. 8 injections at a week interval were given and patients were evaluated at the start of treatment and then at 4th and at 8th week during the treatment and then 4 weeks after the end of treatment. Patents were assessed for mean reduction in scar height, efficacy and complications.

Results: Total of 108 patients completed the study. The mean reduction in the scar height in group B (5-FU+TAC) 1.144+.4717 was markedly better than that of group A (TAC alone) 1.894+1.0751 (t=4.781, p=.000). The efficacy (defined previously as >50% reduction in initial scar height) was superior in group B 44 (77.2%) than that of group A 25 (49.0% (X2=9.260, p=.002). Recurrence was seen in 39.2% (20) of patients of the group A while in only 17.5% (10) of the cases of group B (P=0.012). Mean follow up was of 22 months.

Conclusion: 5-FU+TAC is safe, easy to administer and effective treatment for problematic scars and has the lower rate of recurrence on larger follow up.

Keywords: 5-Fluorouracil; Double blind; Hypertrophic scar; Keloid; Randomized control trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Body Piercing / adverse effects
  • Burns / complications
  • Cicatrix, Hypertrophic / drug therapy*
  • Cicatrix, Hypertrophic / etiology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / therapeutic use*
  • Glucocorticoids / therapeutic use*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Injections, Intralesional
  • Keloid / drug therapy*
  • Keloid / etiology
  • Male
  • Recurrence
  • Treatment Outcome
  • Triamcinolone / therapeutic use*
  • Wounds and Injuries / complications
  • Young Adult


  • Glucocorticoids
  • Immunosuppressive Agents
  • Triamcinolone
  • Fluorouracil