Please use this identifier to cite or link to this item: https://hdl.handle.net/20.500.12104/62769
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-Garcia, I.
Martinez-Fong, D.
Miranda, R.A.
Magana-Castro, R.
Pena-Santoyo, P.
Garcia-Rocha, S.
Bautista, C.A.
Godoy, J.
Flores-Montana, J.
Floresvillar-Mosqueda, J.
Armendariz-Vazquez, O.
Lucano-Landeros, M.S.
Vazquez-Del Mercado, M.
Sanchez-Parada, M.G.
Issue Date: 2012
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. © 2012 by Lippincott Williams & Wilkins.
URI: http://hdl.handle.net/20.500.12104/62769
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