[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epidermolysis-bullosa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epidermolysis-bullosa":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100580187","phase-1-targeting-collagen-vii-antibodies-with-iv-igg-in-dystrophic-epidermolysis-bullosa-100580187",false,"NCT06834035","Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa","IV IgG","Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.\n2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range\n3. Baseline skin blistering greater than 5% total body surface area\n4. 1 wound at least 20 cm\\^2 able to be entirely treated with Vyjuvek weekly\n5. 1 wound at least 20 cm\\^2 that has never been treated with Vyjuvek\n6. Ongoing VYJUVEK treatment.\n\nExclusion Criteria:\n\n1. History of thrombotic event(s)\n2. History of cardiac failure\n3. History of renal failure\n4. IgA deficiency","ALL","6 Years",{"count":19,"type":20},8,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.\n\nFewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.",[27,28,29,30],"Epidermolysis Bullosa","Epidermolysis Bullosa Acquisita","Dystrophic Epidermolysis Bullosa","Recessive Dystrophic Epidermolysis Bullosa",[27,28,29,30,32,33,34,35,36,37,38,39,40,14,41,42,43,44,45,46,47],"Collagen 7","C7","Col7","EB","EBA","DEB","RDEB","Antibodies","Collagen VII","IgG","IVIgG","C7 Antibodies","Collagen 7 Antibodies","Collagen VII Antibodies","Vyjuvek","B-VEC","RECRUITING","2026-04-29",{"date":51,"type":52},"2026-05-05","ACTUAL",{"date":54,"type":52},"2025-08-04",{"date":56,"type":20},"2027-03",{"name":58,"class":59},"M. Peter Marinkovich","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":85,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"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":71,"type":20},6,[73],"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.",[27,76,77,78,79,80,81,82,83,84],"Junctional Epidermolysis Bullosa","Epidermolysis Bullosa, Dystrophic","Epidermolysis Bullosa, Junctional","Skin Abnormalities","Connective Tissue Disease","Collagen Diseases","Skin Diseases","Genetic Diseases, Inborn","Congenital Abnormalities",[86,87],"Filsuvez","Birch Bark extract","2025-12-18",{"date":90,"type":52},"2025-12-22",{"date":92,"type":52},"2025-04-18",{"date":94,"type":20},"2029-09",{"name":96,"class":97},"Chiesi Farmaceutici S.p.A.","INDUSTRY",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":60},"100541475","qualitative-study-in-patients-with-genodermatoses-and-healthcare-professionals-on-reproductive-counselling-100541475","NCT06330350","Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling","Investigating Perspectives of Patients With Genodermatosis and Healthcare Professionals on Reproductive Counselling","Inclusion Criteria:\n\n* Adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children\n* Patients with clinically and molecularly confirmed variant of a genodermatosis\n* Health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists)\n\nExclusion Criteria:\n\n* Not being able to communicate verbally in Dutch or English",{"count":106,"type":20},25,"OBSERVATIONAL","The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.",[110,111,112,27,113,114,115,116,117,118],"Quality of Life","Ichthyosis","Palmoplantar Keratoses","Ectodermal Dysplasia","Basal Cell Nevus Syndrome","Birt-Hogg-Dube Syndrome","Tuberous Sclerosis","Cutis Laxa","Albinism","2025-05-16",{"date":121,"type":52},"2025-05-18",{"date":123,"type":52},"2024-01-01",{"date":125,"type":20},"2025-12-31",{"name":127,"class":59},"Maastricht University Medical Center"]