[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"volume-deficiency-in-the-mid-face\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:volume-deficiency-in-the-mid-face":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624731","prospective-clinical-evaluation-of-the-safety-and-performance-of-the-aesthetic-medical-device-mec-regenerate-injectable-recombinant-collagen-based-product-100624731",false,"NCT07413445","Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)","Inclusion Criteria:\n\n* Both sexes;\n* Caucasian race;\n* Aged between 35 and 65 years;\n* Non-smokers;\n* Willing and able to return to the study site for post-procedural assessments;\n* Agree to attend all study visits without makeup;\n* Agree not to change their habits regarding diet, physical activity, facial makeup, cosmetics, and facial cleansing products;\n* Agree to avoid intense UV exposure (UV sessions or sunbathing) during the entire study period without adequate sun protection;\n* Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use;\n* Agree to sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnancy (applicable only to non-menopausal female subjects);\n* Breastfeeding (applicable only to non-menopausal female subjects);\n* Smokers;\n* Alcohol abuse and\u002For drug use;\n* Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;\n* Body mass index (BMI) variation of ±1 during the study period;\n* History of aesthetic skin treatments (biomaterial implants, facelift, botulinum toxin injections, laser therapy, chemical peels) within 6 months prior to the study start;\n* Previous permanent filler treatments;\n* Changes in normal habits related to diet, physical activity, facial cosmetics, facial cleansing, and makeup within one month prior to the study;\n* Sensitivity or allergy to the investigational product or its components (to be assessed by the investigator at baseline);\n* Predicted poor compliance with study protocol;\n* Participation in a similar study currently or within the past 9 months;\n* Dermatological clinical conditions that could interfere with aesthetic outcomes;\n* Chronic neurological, immunological, metabolic, cardiovascular, pulmonary, renal, or oncological diseases;\n* Current pharmacological treatment with: Anticoagulants, antiplatelet agents, antihistamines, topical or systemic corticosteroids, narcotics, antidepressants, immunosuppressants (except contraceptive or hormonal treatment started more than 1 year prior); Medications that may affect test results as deemed by the investigator.","ALL","35 Years","65 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prospective, spontaneous, open-label pre-market clinical trial with a single injection session; monitoring visits at baseline and 60 days post-treatment.\n\nTwo visits will be conducted during the study:\n\n* a baseline visit, during which the first injection will be administered\n* a final visit, 60 days after the baseline visit, for final assessment\n\nThe experimental design involves injection into the deep subdermal layer with the investigational product during the baseline visit, following the study procedure assessments.\n\nTypically, 0.9 ml per side of the face is administered using the retrograde fan technique.\n\nThe study duration is 2 months; safety evaluation will be conducted using non-invasive instrumental assessments such as skin hydration (corneometry) and medical device safety and subjective assessments (see below).",[26,27,28],"Laxity; Skin","Volume Deficiency in the Mid-Face","Wrinkles","NOT_YET_RECRUITING","2026-02-12",{"date":32,"type":33},"2026-02-17","ACTUAL",{"date":35,"type":20},"2026-03",{"date":37,"type":20},"2026-05",{"name":39,"class":40},"303 Pharma s.r.l.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":17,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100623622","a-study-to-characterize-human-skin-changes-from-biostimulator-treatments-via-non-invasive-imaging-100623622","NCT07399028","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","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.","FEMALE","45 Years",{"count":52,"type":20},25,[23],"Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.",[27,56,57],"Skin Laxity","Photo-aged Skin","RECRUITING","2026-02-02",{"date":61,"type":33},"2026-02-10",{"date":63,"type":33},"2025-10-21",{"date":65,"type":20},"2026-09",{"name":67,"class":40},"Galderma R&D"]