[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xinnate AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Epidermolysis Bullosa (EB)","Dystrophic Epidermolysis Bullosa","Junctional Epidermolysis Bullosa",[30,31],"epidermolysis bullosa","topical treatment","RECRUITING","2026-05-19",{"date":35,"type":36},"2026-05-20","ACTUAL",{"date":38,"type":36},"2026-01-30",{"date":40,"type":20},"2027-06-30",{"name":42,"class":43},"Xinnate AB","INDUSTRY",9,""]