[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"junctional-epidermolysis-bullosa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:junctional-epidermolysis-bullosa":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,82],{"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,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":70,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":56},"100586616","phase-3-a-study-to-learn-about-the-safety-and-efficacy-of-the-drug-oleogel-s10-in-japanese-patients-with-epidermolysis-bullosa-100586616","NCT06917690","A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa","Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)","REVIVE","Inclusion Criteria:\n\n1. Male or female aged ≥ 21 days\n2. Confirmed diagnosis of either JEB or DEB\n3. Both biological parents and all 4 grandparents of Japanese descent\n4. At least 3 EB wounds that meet the following criteria at the time of enrollment:\n\n   * All are located outside of the anogenital region\n   * All are distinguishable from any other wounds on the subject's body (separated by a minimum of 5 cm)\n   * At least one has been present for a minimum of 21 days but less than 9 months AND is 10 cm2 to 50 cm2 in size\n   * At least two have been present for a minimum of 21 days but less than 9 months AND\u002FOR are 10 cm2 to 50 cm2 in size\n5. A female subject must meet one of the following criteria:\n\n   * If of childbearing potential, she must:\n\n     1. Have a negative pregnancy test result at Screening and Baseline Visits, AND\n     2. Agree to use one of the following highly reliable methods of contraception from the day of the informed consent signature until the day after the last Oleogel- S10 application. The following methods are acceptable:\n\n        * Placement of an intrauterine device (IUD) or intrauterine releasing system (IUS)\n        * Combined (both estrogen and progestogen) hormonal contraception (oral) associated with inhibition of ovulation, supplemented with a barrier method (preferably male condom)\n        * Bilateral tubal occlusion\n        * Sexual abstinence, defined as refraining from heterosexual intercourse during the entire study period\n        * Partner vasectomy, provided that the partner is the sole sexual partner and has received medical verification of the surgical success\n   * Be of non-childbearing potential, defined as one of the following:\n\n     * Pre-menarche, OR\n     * Post-menopausal (12 consecutive months of amenorrhea without an alternative medical cause), OR\n     * Permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (supporting evidence required)\n6. Subject and\u002For subject's legal representative has been informed about the study, has read and understood the information provided, and has given written informed consent\n7. Subject and\u002For subject's legal representative is able and willing to follow all study procedures and instructions\n\nExclusion Criteria:\n\n1. Hypersensitivity to Oleogel-S10 or any of its excipients\n2. Diagnosis of EB subtypes simplex or Kindler EB\n3. Receipt of systemic antibiotics for wound-related infections within 7 days prior to enrollment\n4. Receipt of systemic or topical (on EB wounds) steroids within 30 days prior to enrollment Exceptions: Inhaled, ophthalmic, or mucosal applications, such as budesonide suspension for esophageal strictures\n5. Receipt of immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrollment Note: Dupilumab to manage pruritis is allowed if the subject has been on a stable dose for more than 3 months prior to baseline\n6. Receipt of systemic gene therapy for the treatment of inherited EB\n7. Receipt of short-acting stem cell therapy (infusion of Muse cells, allogeneic adipocyte-derived MSC sheet (topically applied), TEMCELL (allogeneic MSCs, subcutaneous injection)) within 6 months prior to study enrollment\n8. Receipt of topical gene therapy for the treatment of inherited EB (e.g., beremagene geperpavec) within 3 months prior to enrollment\n9. Receipt of a JACE® skin graft on any of the target wounds\n10. Current and\u002For former malignancy, including skin malignancies such as basal cell carcinoma and squamous cell carcinoma\n11. Females: Pregnant or lactating, or of childbearing potential with a fertile male partner and unwilling to use a highly reliable method of contraception from the informed consent signature until study participation ends\n12. Enrollment in any other interventional study or treated with any other investigational drug for any disease within 4 weeks prior to enrollment\n13. Presence of any factor in the subject and\u002For legal representative that could interfere with study compliance, such as the ability to attend the scheduled study visits or to properly manage the dressing changes at home","21 Days",{"count":56,"type":21},6,[58],"PHASE3","The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population. Children and adults may participate. The trial also looks at the safety of Oleogel-S10 gel. The main questions it will answer are:\n\n* Does Oleogel-S10 gel close wounds from JEB or DEB within 45 days or reduce the size of the wounds?\n* Are there any medical problems when using Oleogel-S10 gel?\n* How much of the drug ends up in your blood?\n\nThe study has 2 parts. In Part 1, participants will:\n\n* Apply Oleogel-S10 gel to the EB wound dressings at least once every 4 days for 45 days.\n* Visit the clinic once every 2 weeks for checkups and tests. If participants complete Part 1, they may participate in Part 2 if they choose to. In Part 2, participants will continue to receive Oleogel-S10 gel until the product is available to buy in Japan or until the trial is stopped by the company.",[61,29,62,63,64,65,66,67,68,69],"Epidermolysis Bullosa","Epidermolysis Bullosa, Dystrophic","Epidermolysis Bullosa, Junctional","Skin Abnormalities","Connective Tissue Disease","Collagen Diseases","Skin Diseases","Genetic Diseases, Inborn","Congenital Abnormalities",[71,72],"Filsuvez","Birch Bark extract","2025-12-18",{"date":75,"type":37},"2025-12-22",{"date":77,"type":37},"2025-04-18",{"date":79,"type":21},"2029-09",{"name":81,"class":44},"Chiesi Farmaceutici S.p.A.",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100326140","phase-1-gentamicin-for-junctional-epidermolysis-bullosa-100326140","NCT03526159","Gentamicin for Junctional Epidermolysis Bullosa","A Pilot Study of the Restoration of Functional Laminin 332 in JEB Patients With Nonsense Mutations After Topical and Intravenous Gentamicin Treatment","Inclusion Criteria:\n\n1\\. JEB patients with nonsense mutations in the LAMB3 gene in either one or two alleles.\n\nExclusion Criteria:\n\n1. JEB patients who do not have nonsense mutations in the LAMB3 gene in either allele.\n2. Pre-existing known auditory impairment.\n3. Pre-existing known renal impairment.\n4. Pre-existing known allergies to aminoglycosides or sulfate compounds.\n5. Pregnancy.",{"count":56,"type":21},[91,24],"PHASE1","Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes, resulting in loss of laminin 332 and poor epidermal-dermal adherence. Eighty percent of H-JEB patients have LAMB3 mutations and about 95% of these are nonsense mutations. The investigators recently demonstrated that gentamicin readily induced nonsense mutation readthrough and produced full-length laminin beta3 in several nonsense mutations tested. Importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion, and deposition into the dermal-epidermal junction (DEJ). Newly induced laminin 332 reversed abnormal H-JEB cellular phenotypes. Herein, the investigators propose the first clinical trial of gentamicin (by topical and intravenous administration) in JEB patients with nonsense mutations. The milestones will include restored laminin 332 and hemidesmosomes at the DEJ, improved wound closure, and the absence of significant gentamicin side effects.",[29],[95,96,97,98],"Herlitz","Laminin 332","Laminin beta 3","JEB","2020-04-03",{"date":101,"type":37},"2020-04-07",{"date":103,"type":37},"2018-06-01",{"date":105,"type":21},"2020-08-31",{"name":107,"class":108},"University of Southern California","OTHER",1]