[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618517":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":24,"collaborators":11,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":11,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":46,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":11},{"fullName":5,"class":6},"Nordberg Medical AB","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate-treatment group","EXPERIMENTAL",null,[13],"Device: Poly-L-Lactic Acid (Juläine™)",{"label":15,"type":16,"description":11,"interventionNames":17},"Delayed-treatment group (delayed-start control)","OTHER",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Poly-L-Lactic Acid (Juläine™)","Juläine™ is a sterile injectable medical device composed of polylactic acid microspheres.",[15,9],{"type":25,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100618517","prospective-clinical-investigation-to-evaluate-the-safety-and-effectiveness-of-juline-in-improving-gluteal-skin-laxity-in-adults-100618517",false,"NCT07332650","Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.","A Pivotal, Open-Label, Two-Arm, Randomized, Parallel-Group, Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.","Inclusion Criteria:\n\n* Adults aged 18 to 55 years;\n* Body Mass Index (BMI) between 18.5 and 24.95 kg\u002Fm².\n* Skin laxity of the gluteal region defined as sagging and reduced tightness of the skin.\n* Women of childbearing potential must be willing to abide by the contraceptive requirements\n* Ability to understand the study and provide informed consent, attend follow-up visits, and follow post-injection instructions.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or planned pregnancy\u002Flack of adequate contraception (through 8 weeks post-study);\n* Is planning to donate\u002Fbank or retrieve eggs (ova, oocytes) or donate sperm during the study or within 8-weeks of the end of participation of the clinical investigation.\n* Active infection, inflammation or lesions at or near the treatment site.\n* Acute infection at screening;\n* History of autoimmune disease;\n* Immune deficiencies;\n* History of hypertrophic scarring or keloid formation;\n* Previous surgical procedures involving the buttocks\n* Aesthetic procedure on the buttocks (including fillers, elevation wires, radiofrequency, ultrasound, cryotherapy, fat injection, neurotoxin, laser or light treatment, or chemical peel) within 6 months prior to randomization.\n* Hemorrhagic disease or ongoing use of antiplatelets\u002Fanticoagulant therapy.\n* Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).\n* Use of hormonal replacement therapy (HRT) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.\n* Use of topical corticosteroids, topical prescription retinoids in the treatment area within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment.\n* Use of other agents that inhibit collagen production.\n* Known allergy or hypersensitivity to any component of the investigational product.\n* History of herpes simplex rashes, malignant skin diseases, or any other serious dermatologic or systemic disease.\n* Presence of any condition that may impair wound healing (e.g., connective tissue disorders, severe malnutrition).\n* Planned or ongoing cosmetic procedures involving the buttocks or surrounding area during the period of clinical investigation.\n* Extensive tattoos covering \\>50% of the total gluteal area.\n* Participants actively taking GLP-1 medications with the intention of achieving additional weight loss (expected \\>10% during study) will be excluded. Participants on a stable GLP-1 regimen (≥3 months) for diabetes management or weight maintenance, with documented weight stability (±10% in past 6 months) and no planned or expected weight change \\>10%, may be included.\n* Any other medical or psychological condition that, in the opinion of the investigator, may interfere with participation in clinical research or evaluation of results.","ALL","18 Years","55 Years",{"count":37,"type":38},100,"ESTIMATED","INTERVENTIONAL",[41],"NA","This study aims to evaluate the safety and effectiveness of Juläine™ (poly-L-lactic acid) injections for the treatment of buttock skin laxity.\n\nParticipants will be randomized to an immediate-treatment group or a delayed-treatment group. The immediate-treatment group will receive 2 to 3 treatment sessions over up to 2 months and will be compared with the delayed-treatment group during the control period; the delayed-treatment group will receive the same treatment after the delay.\n\nThe primary objective is to assess clinical improvement in buttock skin elasticity 6 months after the last treatment, defined as an increase in skin elasticity measured by a cutometer. Total study participation is up to 16 months, including follow-up.\n\nThis multicenter trial will be conducted in Brazil.",[44,45],"Skin Quality","Skin Laxity",[47,48,49,50,51,52,53,54],"Poly-L-lactic acid","PLLA","Aesthetic","Injectable filler","Buttocks","Gluteal skin laxity","Buttock skin laxity","Skin elasticity","NOT_YET_RECRUITING","2026-03-16",{"date":58,"type":59},"2026-03-19","ACTUAL",{"date":61,"type":38},"2026-10",{"date":63,"type":38},"2027-06",{"name":5,"class":6}]