[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541913":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":36,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Ospedale Tor Vergata","RECRUITING","Roma","00133","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],11.10642,44.99364,{"lat":53,"lon":52},[56,58],{"name":57,"role":34,"phone":35,"phoneExt":36,"email":37},"Elena Campione, Prof",{"name":57,"role":59,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[63],{"name":29,"class":64},"OTHER","100541913","pre-marketing-trial-to-assess-safety-and-efficacy-of-volumizing-filler-based-on-hyaluronic-acid-and-recombinant-collagen-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":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"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",[83,84,85],"Wrinkle","Scar","Laxity; Skin",[87,88,89,90],"hyaluronic acid","Collagen","Filler","Wrinkles","2026-01-22",{"date":93,"type":94},"2026-01-26","ACTUAL",{"date":96,"type":77},"2026-02",{"date":98,"type":77},"2026-06",{"name":5,"class":6},1]