[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suisselle\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100643775","effectiveness-and-safety-of-cellbooster-shape-in-healthy-subjects-100643775",false,"NCT07636512","Effectiveness and Safety of Cellbooster Shape in Healthy Subjects","A Prospective, Open-label Study on the Effectiveness and Safety of Cellbooster® Shape (Stabilized Booster Complex Using CHAC Technology) on Healthy Subjects.","Inclusion Criteria:\n\n1. Healthy subject.\n2. Sex: male and female.\n3. Phototype II to IV.\n4. Age: from 35 years old.\n5. Subject with light to moderate signs of cutaneous ageing of the face.\n6. Subject with a skin hydration rate on cheekbones \\\u003C 60 UA, measured with Corneometer®.\n7. Subject with light to moderate localized submental (double chin) and\u002For malar puffiness (at least 35 in each indication).\n8. Subject looking for an anti-age improvement using an aesthetic procedure.\n9. Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.\n10. Subject having given their free, express, and informed consent.\n11. Subject psychologically able to understand the information related to the study, and to give their written informed consent.\n12. Subject registered to a social security scheme.\n13. Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.\n14. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.\n\nExclusion Criteria:\n\nIn terms of population\n\n1. Pregnant or nursing woman or planning a pregnancy during the study.\n2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.\n3. Subject in a social or sanitary establishment.\n4. Subject participating to another research on human beings or being in an exclusion period for a previous study.\n5. Subject having received a total of 6.000 euros as compensation for their participation in research involving human beings in the last 12 months, including their participation in the present study.\n6. Intensive exposure to sunlight or UV-rays within the previous month and\u002For planning to do so during the study.\n\nIn terms of associated pathology 17. Subject with ongoing uncontrolled depression and\u002For recently recovered (\\\u003C6 months) or psychiatric disorders or any other disorder that may pose a health risk to the subject in the study and\u002For may have an impact on the study assessments, at the investigator appreciation. 18. Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung\u002Fheart disease, neoplasia, malignant blood disease, tumor, HIV, or other major disease (e.g., systemic fungal infection). 19. Subject with recurrent porphyria, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism.\n\n20\\. Subject with any skin or systemic disease (acute and\u002For chronic) likely to interfere with the measured parameters or to put the subject to an undue risk.\n\n21\\. Subject with known history of or suffering from autoimmune disease and\u002For immune deficiency.\n\n22\\. Subject with current cutaneous inflammatory or infectious processes (e.g., acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis \\&), abscess, unhealed wound, or a cancerous or precancerous lesion on the face.\n\n23\\. Subject with multiple severe allergies history, anaphylactic shock history, quincke's oedema, evolutive allergic pathologies.\n\n24\\. Subject having history of allergy or hypersensitivity to one of the components of the tested device.\n\n25\\. Subject having history of hypersensitivity to the antiseptic solution, to lidocaine and\u002For prilocaine or local anesthetics of amide type or one of the excipients of EMLA 5% cream.\n\n26\\. Subject predisposed to keloids or hypertrophic scarring. 27. Subject with coagulation and\u002For homeostasis disorders. 28. Subject with pigmentation disorders (vitiligo, melasma).\n\nRelated to previous or ongoing treatment 29. Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, during the previous month before injection and during the study.\n\n30\\. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.\n\n31\\. Subject having received a COVID vaccination within the past 3 weeks prior to the injection or planning to receive one within the 2 weeks following injection.\n\n32\\. Subject undergoing a topical (on the face) or systemic treatment:\n\n* anti-inflammatory medication during the previous 2 weeks and during the study.\n* anti-histaminics during the previous 7 days.\n* immunosuppressors and\u002For corticoids during the 4 previous weeks and during the study\n* retinoids during the 6 previous months and during the study",true,"ALL","35 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","SUISSELLE has developed a CE marketed (2021) HA-based superficial epidermis\u002Fdermis injection filler and skinbooster product, Cellbooster® Shape (CBS). CBS is produced using patented CHAC Technology. It consists of non-crosslinked HA with L-Carnitine and vitamin C. The device is particularly designed for reducing local puffiness by improving microcirculation and hydration.\n\nThe current post-market clinical investigation is designed to evaluate the efficacy and safety of CBS. For this purpose, healthy subjects with signs of skin aging in the face will receive a 3-session treatment and will be followed-up over 70 days after the initial injection session.\n\nSeveral objective measurements of skin quality will be performed with different instruments allowing to assess skin volume, skin elasticity, skin hydration, and skin microcirculation. Subjective clinical improvement will be evaluated, as well as subject and investigator satisfactions.\n\nThe safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).",[27],"Skin Aging",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Skin aging","Facial aging","Hyaluronic acid","Dermal injection","Skin hydration","Skin elasticity","Microcirculation","Facial puffiness","Global Aesthetic Improvement Scale","Subcutaneous injection","Patient satisfaction","Submental","Periocular","Nasolabial fold","Skin rejuvenation","skin booster","Double chin","Cellbooster","Cellbooster Shape","Fat pad","Malar fat pad","RECRUITING","2026-06-03",{"date":53,"type":54},"2026-06-09","ACTUAL",{"date":56,"type":54},"2026-03-31",{"date":58,"type":21},"2026-08-25",{"name":60,"class":61},"Suisselle","INDUSTRY",""]