A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients
Pathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life. A controlled clinical trial was conducted to evaluate 8% pirfenidone (PFD) gel administered topically 3 times a day during 6 months to 33 pediatr...
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| Veröffentlicht in: | Annals of plastic surgery 2012-01, Vol.68 (1), p.22-28 |
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| creator | Armendariz-Borunda, Juan Lyra-Gonzalez, Ivan Medina-Preciado, David Gonzalez-García, Ignacio Martinez-Fong, Daniel Miranda, Rodolfo Ariel Magaña-Castro, Rogelio Peña-Santoyo, Pedro Garcia-Rocha, Sergio Bautista, Carlos Alfredo Godoy, Jesus Flores-Montana, Jesus Floresvillar-Mosqueda, Jorge Armendariz-Vazquez, Oscar Lucano-Landeros, Martha Silvia Vazquez-Del Mercado, Monica Sanchez-Parada, Maria G |
| description | Pathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life.
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.
Patients treated with PFD during 6 months presented a continuous monthly statistically significant scar regression in comparison with the initial Vancouver measurement (P = |
| doi_str_mv | 10.1097/SAP.0b013e31821b6d08 |
| format | Article |
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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.
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.
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.</description><identifier>ISSN: 0148-7043</identifier><identifier>EISSN: 1536-3708</identifier><identifier>DOI: 10.1097/SAP.0b013e31821b6d08</identifier><identifier>PMID: 21659848</identifier><language>eng</language><publisher>United States</publisher><subject>Administration, Cutaneous ; Adolescent ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Burns - complications ; Child ; Child, Preschool ; Cicatrix, Hypertrophic - drug therapy ; Cicatrix, Hypertrophic - etiology ; Cicatrix, Hypertrophic - therapy ; Compression Bandages ; Drug Administration Schedule ; Female ; Gels ; Humans ; Male ; Pilot Projects ; Prospective Studies ; Pyridones - therapeutic use ; Treatment Outcome</subject><ispartof>Annals of plastic surgery, 2012-01, Vol.68 (1), p.22-28</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c306t-222a7e722ccdf82cd01b7a86f12f0f4ca4358af5b0c0dfd6a7869a5403d875af3</citedby><cites>FETCH-LOGICAL-c306t-222a7e722ccdf82cd01b7a86f12f0f4ca4358af5b0c0dfd6a7869a5403d875af3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21659848$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Armendariz-Borunda, Juan</creatorcontrib><creatorcontrib>Lyra-Gonzalez, Ivan</creatorcontrib><creatorcontrib>Medina-Preciado, David</creatorcontrib><creatorcontrib>Gonzalez-García, Ignacio</creatorcontrib><creatorcontrib>Martinez-Fong, Daniel</creatorcontrib><creatorcontrib>Miranda, Rodolfo Ariel</creatorcontrib><creatorcontrib>Magaña-Castro, Rogelio</creatorcontrib><creatorcontrib>Peña-Santoyo, Pedro</creatorcontrib><creatorcontrib>Garcia-Rocha, Sergio</creatorcontrib><creatorcontrib>Bautista, Carlos Alfredo</creatorcontrib><creatorcontrib>Godoy, Jesus</creatorcontrib><creatorcontrib>Flores-Montana, Jesus</creatorcontrib><creatorcontrib>Floresvillar-Mosqueda, Jorge</creatorcontrib><creatorcontrib>Armendariz-Vazquez, Oscar</creatorcontrib><creatorcontrib>Lucano-Landeros, Martha Silvia</creatorcontrib><creatorcontrib>Vazquez-Del Mercado, Monica</creatorcontrib><creatorcontrib>Sanchez-Parada, Maria G</creatorcontrib><title>A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients</title><title>Annals of plastic surgery</title><addtitle>Ann Plast Surg</addtitle><description>Pathologic skin scarring reversion remains a big challenge for surgeons, as disfiguring scars have a dramatic influence on patient's quality of life.
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.
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.
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.</description><subject>Administration, Cutaneous</subject><subject>Adolescent</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</subject><subject>Burns - complications</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Cicatrix, Hypertrophic - drug therapy</subject><subject>Cicatrix, Hypertrophic - etiology</subject><subject>Cicatrix, Hypertrophic - therapy</subject><subject>Compression Bandages</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gels</subject><subject>Humans</subject><subject>Male</subject><subject>Pilot Projects</subject><subject>Prospective Studies</subject><subject>Pyridones - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0148-7043</issn><issn>1536-3708</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkE1P3DAQhq0KVBbaf1BVvnHKdvwRxzmuUClISEUCzpHjj123WTu1HVUc-ef1AuXAZeYw7_OO9CD0hcCaQN99u9vcrmEEwiwjkpJRGJAf0Iq0TDSsA3mEVkC4bDrg7ASd5vwLgFDJxUd0Qoloe8nlCj1tsI6hpDhN1mA9-eC1mnBJvs6_vuzw7JOzwZsYLPYBl52tV6vK3oaCo8OzKrs4xe0zl3_XSNYqJR-2WKsl19bxEY9LCvmAz9Z4Vdv1gfO1In9Cx05N2X5-3Wfo4fL7_cVVc_Pzx_XF5qbRDERpKKWqsx2lWhsnqTZAxk5J4Qh14LhWnLVSuXYEDcYZoTopetVyYEZ2rXLsDJ2_9M4p_llsLsPeZ22nSQUblzz0pKeUgyA1yV-SOsWck3XDnPxepceBwHBwP1T3w3v3Ffv6-mAZ99a8Qf9ls39nt4Pe</recordid><startdate>201201</startdate><enddate>201201</enddate><creator>Armendariz-Borunda, Juan</creator><creator>Lyra-Gonzalez, Ivan</creator><creator>Medina-Preciado, David</creator><creator>Gonzalez-García, Ignacio</creator><creator>Martinez-Fong, Daniel</creator><creator>Miranda, Rodolfo Ariel</creator><creator>Magaña-Castro, Rogelio</creator><creator>Peña-Santoyo, Pedro</creator><creator>Garcia-Rocha, Sergio</creator><creator>Bautista, Carlos Alfredo</creator><creator>Godoy, Jesus</creator><creator>Flores-Montana, Jesus</creator><creator>Floresvillar-Mosqueda, Jorge</creator><creator>Armendariz-Vazquez, Oscar</creator><creator>Lucano-Landeros, Martha Silvia</creator><creator>Vazquez-Del Mercado, Monica</creator><creator>Sanchez-Parada, Maria G</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201201</creationdate><title>A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients</title><author>Armendariz-Borunda, Juan ; 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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.
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.
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.</abstract><cop>United States</cop><pmid>21659848</pmid><doi>10.1097/SAP.0b013e31821b6d08</doi><tpages>7</tpages></addata></record> |
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| subjects | Administration, Cutaneous Adolescent Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Burns - complications Child Child, Preschool Cicatrix, Hypertrophic - drug therapy Cicatrix, Hypertrophic - etiology Cicatrix, Hypertrophic - therapy Compression Bandages Drug Administration Schedule Female Gels Humans Male Pilot Projects Prospective Studies Pyridones - therapeutic use Treatment Outcome |
| title | A controlled clinical trial with pirfenidone in the treatment of pathological skin scarring caused by burns in pediatric patients |
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