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sjukhuset","Uppsala",{"type":43,"coordinates":139},[140,141],17.63889,59.85882,{"lat":141,"lon":140},[144],{"name":145,"role":146,"phone":25,"phoneExt":25,"email":25},"Katja Holmgren, MD","SUB_INVESTIGATOR",{"type":148,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":160,"type":161},32,"ESTIMATED","INTERVENTIONAL",[164],"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.",[167,168,169],"Epidermolysis Bullosa (EB)","Dystrophic Epidermolysis Bullosa","Junctional Epidermolysis Bullosa",[171,172],"epidermolysis bullosa","topical treatment","2026-05-19",{"date":175,"type":176},"2026-05-20","ACTUAL",{"date":178,"type":176},"2026-01-30",{"date":180,"type":161},"2027-06-30",{"name":5,"class":6},9]