[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619267":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":61,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Galderma R&D","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","All subjects have moderate-to-severe cheek wrinkles and will be treated with Sculptra three times, 4 weeks apart.",[13],"Device: Sculptra®",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Sculptra®","Biostimulator",[9],null,[22,45],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Miami Dermatology & Laser Institute","RECRUITING","Miami","Florida","33133","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-80.19366,25.77427,{"lat":34,"lon":33},[37,42],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Peter Illes","CONTACT","305-279-6060","PeterI@miamidermlaser.com",{"name":43,"role":44,"phone":20,"phoneExt":20,"email":20},"Jill Waibel, MD","PRINCIPAL_INVESTIGATOR",{"facility":46,"status":24,"city":47,"state":47,"zip":48,"country":28,"countryCode":29,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Day Dermatology & Aesthetics","New York","10021",{"type":31,"coordinates":50},[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55,59],{"name":56,"role":39,"phone":57,"phoneExt":20,"email":58},"Caela Startzenbach","212-772-0740","caela@drdorisday.com",{"name":60,"role":44,"phone":20,"phoneExt":20,"email":20},"Doris Day, MD",{"type":62,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100619267","a-clinical-study-to-assess-histological-changes-from-treatment-of-poly-l-lactic-acid-biostimulator-on-women-at-various-menopausal-stages-100619267",false,"NCT07342400","A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages","A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages","Inclusion Criteria:\n\n* Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.\n* Subject with intent to undergo correction of cheek augmentation or contour deficiencies\n* Subjects willing to have a 3-mm punch biopsy on each preauricular side\n* Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg\u002Fm2) throughout the study\n* Ability of giving consent for participation in the study.\n* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.\n\nExclusion Criteria:\n\n* Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.\n* Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.\n* Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.\n* Previous treatment\u002Fprocedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and\u002For study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.\n* Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.","FEMALE","22 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"NA","To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.",[80,81],"Cheek Wrinkles","Menopausal Women","2026-01-13",{"date":84,"type":85},"2026-01-15","ACTUAL",{"date":87,"type":85},"2025-08-12",{"date":89,"type":74},"2026-11",{"name":5,"class":6},2]