[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615451":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":38,"collaborators":19,"id":40,"slug":19,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":19,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":19,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Samyang Biopharmaceuticals Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DMFI150","EXPERIMENTAL","Single injection of DMFI150",[13],"Device: DMFI150",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Injection of DMFI150 for nasolabial folds.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Ocean Clinic","RECRUITING","Marbella","Spain",{"type":27,"coordinates":28},"Point",[29,30],-4.88583,36.51543,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":19,"email":37},"Vanessa","CONTACT","+34 951 775 518","admon@oceanclinic.net",{"type":39,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100615451",false,"NCT07292779","A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds","A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds","Inclusion Criteria:\n\n* Men and women aged 18-70 years.\n* Score of 3 to 4 on the WSRS (1 = absent, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) for both nasolabial folds.\n* Able and willing to provide written informed consent.\n* Willing to refrain from facial cosmetic procedures during the study.\n\nExclusion Criteria:\n\n* Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or 2 weeks after treatment.\n* History or current bleeding disorders.\n* Participation in another clinical trial within 1 month before screening.\n* Pregnant or breastfeeding women, or planning pregnancy.\n* Women of childbearing potential not using effective contraception.","ALL","18 Years","70 Years",{"count":50,"type":51},30,"ESTIMATED","INTERVENTIONAL",[54],"NA","This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.",[57],"Nasolabial Folds, Wrinkles","2026-03-04",{"date":60,"type":61},"2026-03-05","ACTUAL",{"date":63,"type":61},"2025-11-24",{"date":65,"type":51},"2026-12",{"name":5,"class":6},1]