[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597468":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Nordberg Medical AB","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Juläine Group","EXPERIMENTAL","Participants in this arm will receive three intradermal injections of Juläine, an injectable polylactic acid gel, at Day 0, Day 30, and Day 60. Injections are administered into areas affected by atrophic acne scars.",[13],"Device: Juläine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants in this arm will receive three intradermal injections of sterile saline (placebo) at Day 0, Day 30, and Day 60, into areas affected by acne scars.",[19],"Other: Sterile Saline (Placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Juläine","Juläine is a sterile injectable implant containing poly-L-lactic acid microspheres, intended for intradermal use to improve skin depressions from acne scars.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Sterile Saline (Placebo)","Sterile saline solution used as a placebo control, administered in the same volume and schedule as Juläine.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Paweł Kubik, MD, PhD","CONTACT","+48 515 151 388","pawel.kubik@k-lab.com.pl",[39,55],{"facility":40,"status":41,"city":42,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Individual Specialist Medical Practice Maria Luiza-Piesiaków","RECRUITING","Gdansk","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],18.64912,54.35227,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":36,"phoneExt":26,"email":54},"Maria Luiza Piesiaków, MD","maria_luiza@op.pl",{"facility":56,"status":41,"city":57,"state":26,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Centrum Medyczne dr Kubik","Gdynia",{"type":46,"coordinates":59},[60,61],18.53188,54.51889,{"lat":61,"lon":60},[64],{"name":65,"role":35,"phone":36,"phoneExt":26,"email":66},"Daria Albertyńska, MD","daria.albertynska@drkubik.pl",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100597468","evaluation-of-juline-tm-for-the-treatment-of-atrophic-facial-acne-scars-100597468",false,"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","ALL","18 Years",{"count":79,"type":80},55,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86],"Acne Scars",[88,89,90,91,92],"polylactic acid","facial scars","acne","aesthetic","injectable device","2026-03-16",{"date":95,"type":96},"2026-03-18","ACTUAL",{"date":98,"type":96},"2026-03-13",{"date":100,"type":80},"2027-03",{"name":5,"class":6},2]