title: A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients.
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.
authors.affiliation: Department of Molecular Biology and Genomics, Institute for Molecular Biology in Medicine and Gene Therapy, CUCS, University of Guadalajara, Mexico. armdbo@gmail.com
authors.forename: Juan
authors.initials: J
authors.lastname: Armendariz-Borunda
authors.forename: Ivan
authors.initials: I
authors.lastname: Lyra-Gonzalez
authors.forename: David
authors.initials: D
authors.lastname: Medina-Preciado
authors.forename: Ignacio
authors.initials: I
authors.lastname: Gonzalez-García
authors.forename: Daniel
authors.initials: D
authors.lastname: Martinez-Fong
authors.forename: Rodolfo Ariel
authors.initials: RA
authors.lastname: Miranda
authors.forename: Rogelio
authors.initials: R
authors.lastname: Magaña-Castro
authors.forename: Pedro
authors.initials: P
authors.lastname: Peña-Santoyo
authors.forename: Sergio
authors.initials: S
authors.lastname: Garcia-Rocha
authors.forename: Carlos Alfredo
authors.initials: CA
authors.lastname: Bautista
authors.forename: Jesus
authors.initials: J
authors.lastname: Godoy
authors.forename: Jesus
authors.initials: J
authors.lastname: Flores-Montana
authors.forename: Jorge
authors.initials: J
authors.lastname: Floresvillar-Mosqueda
authors.forename: Oscar
authors.initials: O
authors.lastname: Armendariz-Vazquez
authors.forename: Martha Silvia
authors.initials: MS
authors.lastname: Lucano-Landeros
authors.forename: Monica
authors.initials: M
authors.lastname: Vazquez-Del Mercado
authors.forename: Maria G
authors.initials: MG
authors.lastname: Sanchez-Parada
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002056:Burns / Q000150:complications*; D002648:Child; D002675:Child, Preschool; D017439:Cicatrix, Hypertrophic / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D058128:Compression Bandages; D004334:Drug Administration Schedule; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011728:Pyridones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D011728:Pyridones; C093844:pirfenidone