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  • Title: A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients.
    Author: Armendariz-Borunda J, Lyra-Gonzalez I, Medina-Preciado D, Gonzalez-García I, Martinez-Fong D, Miranda RA, Magaña-Castro R, Peña-Santoyo P, Garcia-Rocha S, Bautista CA, Godoy J, Flores-Montana J, Floresvillar-Mosqueda J, Armendariz-Vazquez O, Lucano-Landeros MS, Vazquez-Del Mercado M, Sanchez-Parada MG.
    Journal: Ann Plast Surg; 2012 Jan; 68(1):22-8. PubMed ID: 21659848.
    Abstract:
    BACKGROUND: Pathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life. METHODS: A controlled clinical trial was conducted to evaluate 8% pirfenidone (PFD) gel administered topically 3 times a day during 6 months to 33 pediatric patients with hypertrophic scars caused by burns. 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 Vancouver Scar Scale and a Visual Analog Scale. Safety parameters were determined by the presence of adverse events and monitoring laboratory and hematology parameters. RESULTS: Patients treated with PFD during 6 months presented a continuous monthly statistically significant scar regression in comparison with the initial Vancouver measurement (P = <0.001). PFD group showed a higher improvement of all scar features as compared with control group treated with pressure therapy (P = <0.001). In the PFD group, 9 of 33 patients (27%) had their scores decreased in Vancouver classification by more than 55%, 22 patients (67%) had a 30% to 45% decrease, whereas 2 patients (6%) had a 30% decrease or less. Control group treated with pressure therapy showed a slight improvement in 16% of cases on an average. Patients did not show serious adverse effects or laboratory alterations throughout the study. CONCLUSIONS: Topical administration of 8% PFD gel 3 times a day is more effective and safe in the treatment of hypertrophic scars caused by burns in children, as compared with standard pressure therapy.
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