[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515935":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":47,"responsibleParty":158,"collaborators":45,"id":160,"slug":45,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":45,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":50,"whyStopped":45,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QUTENZA","ACTIVE_COMPARATOR","The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm.\n\nThe second application takes place three months after the first application.",[13],"Drug: Capsaicin 8% patch",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm.\n\nThe second application takes place three months after the first application.",[19],"Device: Hydrocolloid dressing",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Capsaicin 8% patch","Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.",[9],[27],"QUTENZA®",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Hydrocolloid dressing","Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.",[15],[34],"COMFEEL PLUS TRANSPARENT",[36],{"name":37,"affiliation":38,"role":39},"Philippe J LE MOINE, MD","CHU of Brest","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Philippe LE MOINE, MD","CONTACT","+33298223956",null,"philippe.lemoine@chu-brest.fr",[48,62,73,84,95,103,114,125,136,147],{"facility":49,"status":50,"city":51,"state":45,"zip":45,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHU d'Amiens","RECRUITING","Amiens","France",{"type":54,"coordinates":55},"Point",[56,57],2.3,49.9,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":45,"phoneExt":45,"email":45},"Catherine DEVOLDERE",{"facility":63,"status":50,"city":64,"state":45,"zip":45,"country":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHU d'Angers","Angers",{"type":54,"coordinates":66},[67,68],-0.55202,47.47156,{"lat":68,"lon":67},[71],{"name":72,"role":43,"phone":45,"phoneExt":45,"email":45},"Petronela RACHIERU",{"facility":74,"status":50,"city":75,"state":45,"zip":45,"country":52,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"CHU de Bordeaux","Bordeaux",{"type":54,"coordinates":77},[78,79],-0.58046,44.84124,{"lat":79,"lon":78},[82],{"name":83,"role":43,"phone":45,"phoneExt":45,"email":45},"Sylvie BERCIAUD",{"facility":85,"status":50,"city":86,"state":45,"zip":45,"country":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"CHU de Brest","Brest",{"type":54,"coordinates":88},[89,90],-4.48628,48.39029,{"lat":90,"lon":89},[93],{"name":94,"role":43,"phone":45,"phoneExt":45,"email":45},"Philippe LE MOINE",{"facility":96,"status":50,"city":86,"state":45,"zip":45,"country":52,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"CHU de Nantes",{"type":54,"coordinates":98},[89,90],{"lat":90,"lon":89},[101],{"name":102,"role":43,"phone":45,"phoneExt":45,"email":45},"Marine LETELLIER",{"facility":104,"status":50,"city":105,"state":45,"zip":45,"country":52,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"CHU de Lyon","Lyon",{"type":54,"coordinates":107},[108,109],4.84789,45.74906,{"lat":109,"lon":108},[112],{"name":113,"role":43,"phone":45,"phoneExt":45,"email":45},"Sabine SIMONIN",{"facility":115,"status":50,"city":116,"state":45,"zip":45,"country":52,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"CHU de Marseille","Marseille",{"type":54,"coordinates":118},[119,120],5.38107,43.29695,{"lat":120,"lon":119},[123],{"name":124,"role":43,"phone":45,"phoneExt":45,"email":45},"Sylvain REDON",{"facility":126,"status":50,"city":127,"state":45,"zip":45,"country":52,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"CHU de Montpellier","Montpellier",{"type":54,"coordinates":129},[130,131],3.87635,43.61093,{"lat":131,"lon":130},[134],{"name":135,"role":43,"phone":45,"phoneExt":45,"email":45},"Frédéric BERNARD",{"facility":137,"status":50,"city":138,"state":45,"zip":45,"country":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"CHU de Tours","Tours",{"type":54,"coordinates":140},[141,142],0.70398,47.39484,{"lat":142,"lon":141},[145],{"name":146,"role":43,"phone":45,"phoneExt":45,"email":45},"Florence UETTWILLER",{"facility":148,"status":50,"city":149,"state":45,"zip":45,"country":52,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Institut Gustave Roussy","Villejuif",{"type":54,"coordinates":151},[152,153],2.35992,48.7939,{"lat":153,"lon":152},[156],{"name":157,"role":43,"phone":45,"phoneExt":45,"email":45},"Marie-Anne SEVEQUE",{"type":159,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100515935",false,"NCT05997979","Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children","Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y","CAPSAPED","Inclusion Criteria:\n\n* Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling).\n* Male or female.\n* Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations.\n* Neuropathic pain is defined as a DN4 score equal to or greater than 3\u002F7 or 4\u002F10, and localized in a nerve territory explained by the surgery or the trauma.\n* Treatment, survey and follow up must be realized in an identified investigating center of the study\n* For patients of childbearing potential: use of an adequate method of contraception\\* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application).\n\n  * Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)\n\nExclusion Criteria:\n\n* Intellectual deficiency not allowing full filling of NPSI.\n* Insufficient command of the French language to full fill NPSI and other evaluation tools.\n* Parents' refusal of consent.\n* Minor patients' opposition.\n* Underlying neurological disease.\n* Ongoing neurotoxic treatment.\n* Already treated by capsaicin.\n* Cutaneous lesion on pain area.\n* Patient presenting a pain area on the face, above the hairline of the scalp, and\u002For in proximity to mucous membranes\n* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.","ALL","12 Years","17 Years",{"count":171,"type":172},46,"ESTIMATED","INTERVENTIONAL",[175],"PHASE3","This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery.\n\nIt is a multicentric randomized controlled superiority trial in parallel arms :\n\n* experimental arm: Capsaicin 8% cutaneous patch\n* controlled arm : Hydrocolloid dressing\n\nTreatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed.\n\nTolerance is assessed during each application and by phone call in following days until stop of cold need.\n\nEfficacy is assessed monthly by clinical consultation until the end of the study (month 4).",[178,179],"Neuropathic Pain","Chronic Pain",[178,181,182,183],"Pediatric","Capsaicin","Randomized clinical trial","2026-06-12",{"date":186,"type":187},"2026-06-15","ACTUAL",{"date":189,"type":187},"2024-03-05",{"date":191,"type":172},"2028-07-05",{"name":5,"class":6},10]