[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07399028":3,"trial-entities:NCT07399028":89,"trial-summary:NCT07399028":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":64,"locations":67,"central_contacts":85,"overall_officials":86,"references":87,"see_also_links":88},"NCT07399028","GLI.04.US.SL.050","A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging","A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging","RECRUITING","2026-09","2026-01","2026-02-10","2025-10-21","Galderma R&D","INDUSTRY",false,"Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.",null,[19,20,21],"Volume Deficiency in the Mid-Face","Skin Laxity","Photo-aged Skin",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},25,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Sculptra®","Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.",[36],"Treatment Group",[38],{"measure":39,"description":40,"timeFrame":41},"Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging","Images taken with VISIA imaging system and an imaging system using tomography technology at baseline and post-baseline timepoints will be compared to assess structural changes in cheeks.","4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline",[],"FEMALE","45 Years","65 Years",{"inclusion":47,"exclusion":58,"raw_text":63},[48,49,50,51,52,53,54,55,56,57],"Adult subjects aged 45-65 years old","Females only","Subject with moderate-to-severe cheek wrinkles on the GCWS","Subject with intent to undergo correction of cheek wrinkles on both sides of the face","Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes","Subject willing to be photographed at each visit.","Subjects willing to stop using current facial skincare products for the duration of the study.","Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.","Ability to read, understand and give consent for participation in the study.","Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.",[59,60,61,62],"Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.","Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.","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.","Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.","Inclusion Criteria:\n\n* Adult subjects aged 45-65 years old\n* Females only\n* Subject with moderate-to-severe cheek wrinkles on the GCWS\n* Subject with intent to undergo correction of cheek wrinkles on both sides of the face\n* Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes\n* Subject willing to be photographed at each visit.\n* Subjects willing to stop using current facial skincare products for the duration of the study.\n* Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.\n* Ability to read, understand and give consent for participation in the study.\n* Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.\n\nExclusion Criteria:\n\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.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"Luxurgery","New York","10021","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Christina Uong","CONTACT","212-508-0000","cku@luxurgery.com",{"name":80,"role":81},"Sachin Shridarani, MD","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},40.71427,-74.00597,[],[],[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91,21,19],"Cutis Laxa",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study with a planned enrollment of 25 women. It is not specified if it is randomized or blinded.","completed","Study of Sculptra for Mid-Face Volume and Skin Changes","This study is looking at how Sculptra® injections affect the skin in the mid-face area. Researchers want to see if Sculptra can improve volume deficiency, skin looseness (laxity), and sun-damaged (photo-aged) skin. You might be able to join if you are a woman between 45 and 65 years old with moderate to severe wrinkles in your cheeks. The main goal is to measure changes in your mid-face using special imaging tools after Sculptra treatment. The study is currently unclear on its recruitment status and plans to enroll 25 participants.","Participants will be followed for 20 weeks after their initial treatment to assess structural changes in the mid-face.",89,"Participants will receive Sculptra injections in their cheeks and will have imaging assessments at 4, 8, 12, 16, and 20 weeks after the initial treatment. You will also need to be photographed at each visit.","Not stated in the trial record.",[33],"v2"]