[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541913":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":61,"id":64,"slug":36,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":36,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":36,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Taumedika s.r.l.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Face treatment","EXPERIMENTAL","Patients treated for face needs with Karisma micro injections",[13],"Device: Karisma",{"label":15,"type":10,"description":16,"interventionNames":17},"Lips treatment","Patients treated for face needs with Karisma microinjections",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Karisma","Intradermal injection",[9,15],[25],"Karisma filler",[27],{"name":28,"affiliation":29,"role":30},"Adolfo Gasparetto, MD","Nextrasearch S.r.l.s.","STUDY_DIRECTOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Elena Campione, Professor","CONTACT","+393382445642",null,"elena.campione@uniroma2.it",{"name":28,"role":34,"phone":39,"phoneExt":36,"email":40},"+393356641965","adolfogasparetto@nextrasearch.it",[42],{"facility":43,"status":44,"city":45,"state":36,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ospedale Tor Vergata","RECRUITING","Roma","00133","Italy",{"type":49,"coordinates":50},"Point",[51,52],11.10642,44.99364,{"lat":52,"lon":51},[55,57],{"name":56,"role":34,"phone":35,"phoneExt":36,"email":37},"Elena Campione, Prof",{"name":56,"role":58,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[62],{"name":29,"class":63},"OTHER","100541913",false,"NCT06336044","Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'","\"Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'\"","Inclusion Criteria:\n\n* all sexes\n* caucasic\n* 18 to 70 years\n* non smoker\n\nExclusion Criteria:\n\n* Pregnancy\n* milking\n* smoker\n* alcohol or drugs abuse\n* change of BMI during the study\n* previous facial surgery, implants, permanent treatments\n* sensitivity to the product\n* dermatological difficult frame\n* health weakness\n* treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results","ALL","18 Years","70 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events",[81,82,83],"Wrinkle","Scar","Laxity; Skin",[85,86,87,88],"hyaluronic acid","Collagen","Filler","Wrinkles","2026-01-22",{"date":91,"type":92},"2026-01-26","ACTUAL",{"date":94,"type":75},"2026-02",{"date":96,"type":75},"2026-06",{"name":5,"class":6},1]