[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nordberg Medical AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Skin Quality","Skin Laxity",[30,31,32,33,34,35,36,37],"Poly-L-lactic acid","PLLA","Aesthetic","Injectable filler","Buttocks","Gluteal skin laxity","Buttock skin laxity","Skin elasticity","NOT_YET_RECRUITING","2026-03-16",{"date":41,"type":42},"2026-03-19","ACTUAL",{"date":44,"type":21},"2026-10",{"date":46,"type":21},"2027-06",{"name":48,"class":49},"Nordberg Medical AB","INDUSTRY",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100597468","evaluation-of-juline-tm-for-the-treatment-of-atrophic-facial-acne-scars-100597468","NCT07058883","Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars","Prospective, Randomized, Placebo-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Juläine (Polylactic Acid) in the Treatment of Facial Acne Scars","Inclusion Criteria:\n\n* Age 18 years or older\n* Presence of moderate to severe atrophic facial acne scars\n* Immune-competent adult\n* Willing and able to comply with study procedures and follow-up visits\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Active acne, infection, or chronic skin disease in the treatment area\n* Known allergy or hypersensitivity to any component of Juläine\n* History of keloid formation or hypertrophic scarring\n* Current anticoagulant therapy or bleeding disorder\n* Pregnant or breastfeeding\n* Previous aesthetic treatment in the same area within the past 6 months\n* Participation in another interventional clinical trial within 30 days before enrollment",{"count":58,"type":21},55,[24],"This study aims to evaluate the effectiveness and safety of Juläine, an injectable medical device made of polylactic acid, for treating facial acne scars. Participants with atrophic acne scars will be randomly assigned to receive either Juläine or a placebo (saline). The treatment will consist of three injection sessions over two months, followed by a 12-month observation period. The study will measure changes in scar severity and skin quality over time using clinical assessments and imaging tools. The study is being conducted at multiple dermatology clinics in Poland and is approved by a local ethics committee.",[62],"Acne Scars",[64,65,66,67,68],"polylactic acid","facial scars","acne","aesthetic","injectable device","RECRUITING",{"date":71,"type":42},"2026-03-18",{"date":73,"type":42},"2026-03-13",{"date":75,"type":21},"2027-03",{"name":48,"class":49},""]