[{"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":36,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":36,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":36,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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",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":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"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",[82,83,84],"Wrinkle","Scar","Laxity; Skin",[86,87,88,89],"hyaluronic acid","Collagen","Filler","Wrinkles","2026-01-22",{"date":92,"type":93},"2026-01-26","ACTUAL",{"date":95,"type":76},"2026-02",{"date":97,"type":76},"2026-06",{"name":5,"class":6},1]