Aim

An open, controlled, prospective, and pilot clinical trial to evaluate the efficacy and safety of pirfenidone gel in the treatment of hypertrophic scars caused by burns from different etiologies.

Methods

  • Patients enrolled in this clinical trial had scar evolution time ranging from 3 to 36 months, and the clinical characteristics of hypertrophic scars in pirfenidone and pressure therapy were closely comparable.
  • 33 pediatric patients with burn scars were enrolled for treatment with 8% pirfenidone gel 3 times a day for 6 months.
  • A total of 30 patients with hypertrophic scars with identical Vancouver Scar Scale values were treated with pressure therapy and included as controls.
  • Improvements were evaluated by the Vancouver Scar Scale (VSS) and a Visual Analog Scale (VAS).
  • Safety parameters were determined by the presence of adverse events and monitoring of laboratory and hematology parameters.

Results

  • Patients treated with pirfenidone presented a continuous monthly statistically significant scar regression in comparison with the initial Vancouver measurement (P=< 0.001). (Figure 4)
  • The pirfenidone group showed a greater improvement in VSS and VAS scores as compared with the control group treated with pressure therapy (P=<0.001)
  • In the pirfenidone group, 27% patients had decreased their Vancouver scores by more than 55%, 67% patients had a 30% to 45% decrease, and 6% patients had a 30% decrease or less. (Figure 5)
  • Patients in pressure therapy experienced only a 16% average decrease in VSS clinical features.
  • Patients did not show serious adverse effects or laboratory alterations throughout the study.

Conclusion

The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.