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      "canonicalId": "NCT06594393",
      "title": "A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study",
      "scientificTitle": "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",
      "status": "recruiting",
      "studyType": "interventional",
      "phase": [
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      "conditions": [
        "Epidermolysis Bullosa (EB)",
        "Dystrophic Epidermolysis Bullosa",
        "Junctional Epidermolysis Bullosa"
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          "name": "TCP-25 gel",
          "type": "DRUG",
          "description": "Topical gel"
        },
        {
          "name": "Vehicle (placebo)",
          "type": "DRUG",
          "description": "Placebo gel"
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      "sponsor": {
        "name": "Xinnate AB",
        "type": "INDUSTRY"
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          "city": "Cincinnati",
          "country": "United States",
          "facility": "Cincinnati Children's Hospital Medical Center"
        },
        {
          "city": "Paris",
          "country": "France",
          "facility": "Hopital St Louis"
        },
        {
          "city": "Athens",
          "country": "Greece",
          "facility": "Andreas Syngros Hospital of Veneral & Dermatological Diseases"
        },
        {
          "city": "Thessaloniki",
          "country": "Greece",
          "facility": "Hospital Of Skin And Venereal Diseases of Thessaloniki"
        },
        {
          "city": "Modena",
          "country": "Italy",
          "facility": "Hospital"
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        {
          "city": "Rome",
          "country": "Italy",
          "facility": "IDI Istituto Dermopatico dell'Immacolata IRCCS"
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        {
          "city": "Gdansk",
          "country": "Poland",
          "facility": "University hospital"
        },
        {
          "city": "Lodz",
          "country": "Poland",
          "facility": "Dermoklinika Centrum Medyczne"
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        {
          "city": "Barcelona",
          "country": "Spain",
          "facility": "San Joan de Deu, SJD Children's hospital Barcelona"
        },
        {
          "city": "Barcelona",
          "country": "Spain",
          "facility": "Hospital Clinic de Barcelona"
        },
        {
          "city": "Madrid",
          "country": "Spain",
          "facility": "Hospital Univ La Paz"
        },
        {
          "city": "Lund",
          "country": "Sweden",
          "facility": "University hospital"
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        {
          "city": "Uppsala",
          "country": "Sweden",
          "facility": "Akademiska sjukhuset"
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        "primary": [
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          "Change in procedural pain using the Wong Baker FACES® Pain Rating Scale (0 min -10 max)",
          "Change from baseline in clinical impression of overall treatment area",
          "TCP-25 plasma concentrations",
          "Number of participants with treatment-related local tolerability assessment at the area of IMP application assessed on a 4-point scale",
          "Clinically significant changes from baseline in blood pressure until end of treatment",
          "Number of patients with clinically significant changes from baseline in pulse rate until end of treatment",
          "Number of patients with clinically significant changes from baseline in physical examination findings until end of treatment"
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        "criteria": "Inclusion Criteria:\n\n* Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or 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/or 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/kg 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.",
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        "count": 32
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      "startDate": "2026-01-30",
      "completionDate": "2027-06-30",
      "lastUpdated": "2026-10-22T00:00:00.000Z",
      "firstPosted": "2024-09-19T00:00:00.000Z",
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