[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561763":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":142,"collaborators":25,"id":144,"slug":25,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":25,"enrollmentInfo":153,"targetDuration":25,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":164,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Xinnate AB","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TCP-25","EXPERIMENTAL","Topical gel",[13],"Drug: TCP-25 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Paz","Madrid",{"type":42,"coordinates":109},[110,111],-3.70256,40.4165,{"lat":111,"lon":110},{"facility":114,"status":115,"city":116,"state":117,"zip":118,"country":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"University hospital","NOT_YET_RECRUITING","Lund","Skåne County","23735","Sweden",{"type":42,"coordinates":121},[122,123],13.19321,55.70584,{"lat":123,"lon":122},[126],{"name":127,"role":32,"phone":128,"phoneExt":25,"email":129},"Principal investigator","46 46 17 100","info@regionskane.se",{"facility":131,"status":38,"city":132,"state":25,"zip":25,"country":119,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Akademiska sjukhuset","Uppsala",{"type":42,"coordinates":134},[135,136],17.63889,59.85882,{"lat":136,"lon":135},[139],{"name":140,"role":141,"phone":25,"phoneExt":25,"email":25},"Katja Holmgren, MD","SUB_INVESTIGATOR",{"type":143,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100561763",false,"NCT06594393","A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study","A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa","STEP","Inclusion Criteria:\n\n* Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and\u002For by a skin biopsy with immunofluorescence mapping.\n* Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.\n\nExclusion Criteria:\n\n* The patient has any subtype of EB other than DEB or JEB.\n* The patient is currently being treated or planned to be treated with systemic antibiotics.\n\nNote: Use of preventive and\u002For anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.\n\n• Use of systemic corticosteroids \\>0.2 mg\u002Fkg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.\n\nNote: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.\n\n• The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.","ALL","4 Years",{"count":154,"type":155},32,"ESTIMATED","INTERVENTIONAL",[158],"PHASE2","This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.",[161,162,163],"Epidermolysis Bullosa (EB)","Dystrophic Epidermolysis Bullosa","Junctional Epidermolysis Bullosa",[165,166],"epidermolysis bullosa","topical treatment","2026-05-19",{"date":169,"type":170},"2026-05-20","ACTUAL",{"date":172,"type":170},"2026-01-30",{"date":174,"type":155},"2027-06-30",{"name":5,"class":6},9]