[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627143":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University Hospital Schleswig-Holstein","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki",null,"This cohort includes patients diagnosed with moderate-to-severe atopic dermatitis involving the genital region who are treated with tralokinumab as part of routine clinical care over 52 weeks. Data will be collected at baseline and follow-up visits to assess clinical outcomes and patient-reported measures.",[13],"Drug: tralokinumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","tralokinumab","Patients receive tralokinumab as part of routine clinical care according to the licensed product label and physician's clinical decision. The study is observational and does not dictate or assign treatment; it collects data on patients treated with tralokinumab under real-world conditions.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Inga Brouer","CONTACT","+4945150041626","IngaCatharina.Brouer@uksh.de",[27,46],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Department of Dermatology of the University Hospital Augsburg","RECRUITING","Augsburg","München","86156","Germany","DE",{"type":36,"coordinates":37},"Point",[38,39],10.89851,48.37154,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":10,"email":45},"Andreas Prof. Wollenberg, Prof.","+49 821 400-01","info@uk-augsburg.de",{"facility":47,"status":29,"city":48,"state":49,"zip":50,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"CCIM, Institut für Entzündungsmedizin UKSH Lübeck","Lübeck","Schleswig-Holstein","23538",{"type":36,"coordinates":52},[53,54],10.68729,53.86893,{"lat":54,"lon":53},[57,60],{"name":58,"role":23,"phone":59,"phoneExt":10,"email":25},"Diamant Prof. Thaci, Prof.","0451 500 - 41601",{"name":61,"role":62,"phone":10,"phoneExt":10,"email":10},"Prof. Diamant Thaci, Prof.","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[66],{"name":67,"class":68},"LEO Pharma","INDUSTRY","100627143","intervention-with-tralokinumab-in-patients-with-moderate-to-severe-atopic-dermatitis-with-genital-impact-100627143",false,"NCT07444801","Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact","AD Genital","Inclusion Criteria:\n\n* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.\n* Subjects must be at least 18 years of age at time of enrollment.\n* Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.\n* Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label.\n\nExclusion Criteria:\n\n* Exclusion criteria will comply with the licensed specifications for tralokinumab.\n* Subjects incapable of giving full informed consent.\n* Current participation in another study with any investigational products (noninterventional or registries are allowed).\n* Currently pregnant or nursing women will be excluded from this study.\n* Subjects without genital involvement","ALL","18 Years",{"count":79,"type":80},30,"ESTIMATED","OBSERVATIONAL","Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)",[84],"Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region",[86,87,88,89,90],"atopic dermatits","Moderate-to-Severe Atopic Dermatitis","Genital Atopic Dermatitis","Tralokinumab","Non-Interventional Study","2026-02-24",{"date":93,"type":94},"2026-03-03","ACTUAL",{"date":96,"type":94},"2025-10-20",{"date":98,"type":80},"2028-06-30",{"name":5,"class":6},2]