• Annals of plastic surgery · Jan 2012

    Comparative Study Controlled Clinical Trial

    A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients.

    • Juan Armendariz-Borunda, Ivan Lyra-Gonzalez, David Medina-Preciado, Ignacio Gonzalez-García, Daniel Martinez-Fong, Rodolfo Ariel Miranda, Rogelio Magaña-Castro, Pedro Peña-Santoyo, Sergio Garcia-Rocha, Carlos Alfredo Bautista, Jesus Godoy, Jesus Flores-Montana, Jorge Floresvillar-Mosqueda, Oscar Armendariz-Vazquez, Martha Silvia Lucano-Landeros, Monica Vazquez-Del Mercado, and Maria G Sanchez-Parada.
    • Department of Molecular Biology and Genomics, Institute for Molecular Biology in Medicine and Gene Therapy, CUCS, University of Guadalajara, Mexico. armdbo@gmail.com
    • Ann Plast Surg. 2012 Jan 1;68(1):22-8.

    BackgroundPathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life.MethodsA 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.ResultsPatients 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.ConclusionsTopical 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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