[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623602":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":19,"locations":28,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":7,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":7,"enrollmentInfo":68,"targetDuration":7,"studyType":71,"phases":7,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":31,"whyStopped":7,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Yuvell","OTHER",null,[9,15],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Saypha® Rich","Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use.",[14],"hyaluronic acid",{"type":10,"name":16,"description":12,"armGroupLabels":7,"otherNames":17},"Saypha® Filler Lidocaine",[18],"hyaluronic acid with lidocaine",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":7,"email":24},"Mia Cajkovsky","CONTACT","+43 1 512 13 25 30","mia.cajkovsky@yuvell.at",{"name":26,"role":22,"phone":23,"phoneExt":7,"email":27},"Michelle Friedrich, MSc","michelle.friedrich@yuvell.at",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"YUVELL","RECRUITING","Vienna","State of Vienna","1010","Austria","AT",{"type":38,"coordinates":39},"Point",[40,41],16.37208,48.20849,{"lat":41,"lon":40},[44,45,46,49],{"name":21,"role":22,"phone":23,"phoneExt":7,"email":24},{"name":26,"role":22,"phone":23,"phoneExt":7,"email":27},{"name":47,"role":48,"phone":7,"phoneExt":7,"email":7},"Leo Richter, Dr.","PRINCIPAL_INVESTIGATOR",{"name":50,"role":51,"phone":7,"phoneExt":7,"email":7},"Mahtab Saidi-Zecha, Dr.","SUB_INVESTIGATOR",{"type":53,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[55],{"name":56,"class":57},"Croma-Pharma GmbH","INDUSTRY","100623602","prospective-non-interventional-study-assessing-perioral-rejuvenation-procedure-100623602",false,"NCT07398768","Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure","A Prospective, Non-interventional, Single-Centre Study Assessing the Time Course of a Holistic Perioral Rejuvenation Procedure","Inclusion Criteria:\n\n1. 18 years or older at time of treatment.\n2. At least mild static perioral lines and maximum of thin lips, as assessed by the investigator.\n3. Participant has a stable medical condition with no uncontrolled systemic disease.\n4. Willingness to participate in the routine follow-up after 12 weeks and a signed ICF.\n5. Participant already visiting the clinic for the specific treatment.\n\nExclusion Criteria:\n\n1. Pregnancy and breast feeding.\n2. Known impairment of blood coagulation.\n3. Presence of acute infection or inflammation at the proposed injection sites.\n4. Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months.\n5. Patients with a history of autoimmune disease or who are receiving immune therapy.\n6. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amidetype local anaesthetics.",true,"ALL","18 Years",{"count":69,"type":70},34,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are:\n\n* What proportion of participants achieves a ≥1-point improvement from baseline on both the Lip Fullness Scale (LFS) and the Static Perioral Lines Assessment Scale (SPLAS) at Week 12?\n* How do skin wrinkling\u002Fsurface roughness, lip and perioral volume, and patient satisfaction change over 6 and 12 weeks?\n\nParticipants will:\n\n* Receive a routine (non-study-mandated) holistic perioral rejuvenation procedure as decided by their treating clinician.\n* Attend study visits at approximately baseline, Week 6, and Week 12.\n* Undergo independent clinical assessments (assessor not involved in treatment delivery) of LFS and SPLAS.\n* Have skin wrinkling and surface roughness documented by VISIA skin analysis (baseline, Week 6, Week 12).\n* Have lip and perioral volume measured by VECTRA M3 volume analysis (baseline, Week 6, Week 12).\n* Complete a standardized patient satisfaction questionnaire (Week 12).",[74,75,76,77],"Perioral Wrinkles","Crow's Feet","Lip Volume Enhancement","Lip Aging",[79,80,81,14],"smoker's lines","perioral wrinkles","perioral lines","2026-03-12",{"date":84,"type":85},"2026-03-13","ACTUAL",{"date":87,"type":85},"2026-02-13",{"date":89,"type":70},"2026-07",{"name":5,"class":6},1]