[{"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:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100561763","phase-2-a-phase-2-study-of-tcp-25-gel-in-patients-with-epidermolysis-bullosa-step-study-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":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Epidermolysis Bullosa (EB)","Dystrophic Epidermolysis Bullosa","Junctional Epidermolysis Bullosa",[31,32],"epidermolysis bullosa","topical treatment","RECRUITING","2026-05-19",{"date":36,"type":37},"2026-05-20","ACTUAL",{"date":39,"type":37},"2026-01-30",{"date":41,"type":21},"2027-06-30",{"name":43,"class":44},"Xinnate AB","INDUSTRY",9,""]