[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epidermolysis-bullosa-eb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epidermolysis-bullosa-eb":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,110,163,190,209],{"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":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":54,"type":21},100,[56],"PHASE4","This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,27,90,91,92,93,94,95,96,97,98],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pyoderma Gangrenosum","Pterygium","Hypospadias","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Invasive Fungal Infection","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Pouchitis","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","NOT_YET_RECRUITING","2026-05-01",{"date":102,"type":37},"2026-05-05",{"date":104,"type":21},"2026-08",{"date":106,"type":21},"2035-12",{"name":108,"class":109},"Jay C. Buckey Jr.","OTHER",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100593834","phase-1-targeting-collagen-vii-antibodies-in-bullous-diseases-using-efgartigimod-iv-vyvgart-100593834","NCT07011589","Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)","Inclusion Criteria:\n\n* For DEB patients (aged 12 years or older): DEB confirmed with mutation analysis and correlated by phenotype, and treatment of at least 1 wound treated with topical gene therapy (VYJUVEK). Presence of C7 antibodies above normal cutoff on ELISA.\n* For (classic) EBA patients (aged 18 years or older): EBA confirmed with positive histopathology (DIF), C7 antibodies above normal cutoff on ELISA, and having at least 1 skin lesion.\n* The participant has a Karnofsky performance status of at least 60% at screening.\n* Contraceptive use by reproductive male and female patients should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:\n\n  1. Male participants:\n\n     \\- Must agree to use an acceptable method of contraception and not donate sperm from the time that the ICF is signed until they have received their last dose of IMP.\n  2. Female participants:\n\n     * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at week 1 \u002F baseline before study intervention can be administered. Subsequent urine pregnancy tests are to be completed at week 6, week 11, week 16, week 21, and week 26 \u002F EoS.\n     * WOCBP must agree to use a highly effective or acceptable contraception method until at least 90 days after they receive their last dose of IMP.\n\nExclusion Criteria:\n\n* Linear IgA dermatosis-like EBA or other autoimmune blistering diseases (including but not limited to pemphigus vulgaris, bullous pemphigoid, mucous membrane pemphigoid).\n* Use of the following EBA treatments:\n\n  * sulfasalazine, IVIg, subcutaneous administration of immunoglobulin (SCIg), immunoadsorption or plasma exchange within 2 weeks of the screening visit, tetracyclines with or without nicotinamide at doses higher than the recommended daily allowance (RDA)\u002Fdietary reference intake (DRI) within 2 weeks of the screening visit.\n  * any monoclonal antibody (including rituximab or another anti-CD20 biologic) within 6 months of the screening visit.\n  * complementary therapies-such as traditional Chinese medicines, herbs, or procedures (e.g., acupuncture)-within 4 weeks (or 5 half-lives) of the screening visit, if the investigator determines that such therapies may interfere with the study's efficacy assessments and\u002For potentially risk the safety of the participant.\n  * The use of the following EBA treatments is permitted throughout the study: OCS, topical corticosteroids, conventional immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, mycophenolate, or mofetil), and dapsone.\n* Moderate to severe renal insufficiency.\n* Known contraindication to OCS therapy.\n* Clinically significant uncontrolled active or chronic, bacterial, viral, or fungal infection at screening\n* Medical instability limiting ability to travel to the Investigative Center\n* Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits\u002Fprocedures, as determined by the investigator.\n* Subjects actively receiving chemotherapy or immunotherapy at screening\n* Active drug or alcohol addiction as determined by the investigator.\n* Pregnant or nursing women\n* History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to screening:\n\n  1. Basal cell or squamous cell skin cancer\n  2. Carcinoma in situ of the cervix\n  3. Carcinoma in situ of the breast\n  4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)","12 Years",{"count":118,"type":21},18,[120,24],"PHASE1","The study objective is to see if IV Efgartigimod and Vyjuvek treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and IV Efgartigimod treatment in Epidermolysis Bullosa Acquisita (EBA) improves wound healing and affects the levels of C7 antibody levels in serum.\n\nFewer wounds, more rapidly healing wounds, and decreased C7 antibodies could improve quality of life.",[27,123,124,28],"Epidermolysis Bullosa Acquisita","Recessive Dystrophic Epidermolysis Bullosa",[31,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"epidermolysis bullosa acquisita","dystrophic epidermolysis bullosa","recessive dystrophic epidermolysis bullosa","recessive","dystrophic","epidermolysis","bullosa","acquisita","collagven 7","c7","Col7","EB","EBA","DEB","RDEB","antibodies","Collagen VII","VII","IV IgG","IgG","IV","IVIgG","C7 antibodies","Collagen 7 antibodies","Collagen VII Antibodies","Vyjuvek","B-VEC","Efgartigimod","2026-04-29",{"date":102,"type":37},{"date":157,"type":21},"2026-07",{"date":159,"type":21},"2028-01",{"name":161,"class":109},"M. Peter Marinkovich",1,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":116,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100630062","phase-3-efficacy-and-safety-study-to-evaluate-sd-101-in-epidermolysis-bullosa-100630062","NCT07482787","Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa","A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa","Inclusion Criteria:\n\n1. Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.\n2. Patient (or caretaker) must be willing to comply with all protocol requirements.\n3. Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB.\n4. Patient must have 1 target wound (size 10 to 50 cm2).\n5. Patients must be between 28 days to 12 years at study entry\n6. Target wound must be present for 21 days or more.\n7. Patients must have wound burden based on BSA of ≥5% at baseline\n\nExclusion Criteria:\n\n1. Patients who do not meet the entry criteria outlined above.\n2. Selected target wound cannot have clinical evidence of local infection.\n3. Use of any investigational drug or approved EB therapy within 30 days before enrollment.\n4. Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.\n5. Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)\n6. Use of systemic antibiotics within 7 days before enrollment.\n7. Current or former malignancy.\n8. Participant is one of the following:\n\n   1. Not of childbearing potential (premenarchal or male\u002Fnot in possession of a uterus).\n   2. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:\n\n      * Abstinence from heterosexual intercourse as a lifestyle choice.\n      * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.\n      * Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.","28 Days",{"count":172,"type":21},80,[174],"PHASE3","The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).",[27],[178,179,180],"Wound closure","Itching","Wound burden","2026-03-18",{"date":183,"type":37},"2026-03-20",{"date":185,"type":21},"2026-05-15",{"date":187,"type":21},"2027-06-17",{"name":189,"class":44},"Paradigm Therapeutics",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":116,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100630064","phase-3-an-open-label-extension-safety-study-to-evaluate-sd-101-in-epidermolysis-bullosa-100630064","NCT07482813","An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa","An Open Label Extension, Multi-Center Study to Evaluate the Safety of SD 101 Cream in Subjects With Epidermolysis Bullosa","Inclusion Criteria:\n\n1. ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.\n2. Subject (or caretaker) must be willing to comply with all protocol requirements.\n3. Subjects must complete the SD-007 study.\n\nExclusion Criteria:\n\n1. Subjects who do not meet the entry criteria outlined above.\n2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator)\n3. Participant is one of the following:\n\n   1. Not of childbearing potential (premenarchal or male\u002Fnot in possession of a uterus).\n   2. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:\n\n      * Abstinence from heterosexual intercourse as a lifestyle choice.\n      * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.\n      * Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.",{"count":172,"type":21},[174],"The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.",[27],"2026-03-16",{"date":203,"type":37},"2026-03-19",{"date":205,"type":21},"2026-07-15",{"date":207,"type":21},"2027-08-19",{"name":189,"class":44},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":220,"conditions":221,"keywords":230,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968","NCT07312513","Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n  * Venous lower leg ulcer\n  * Arterial ulcer\n  * Diabetic ulcer\n  * Pressure ulcer\n  * Post-operative wound healing by secondary intention\n  * Traumatic wound\n  * Surgical wound\n  * Burn or scald (grade III: after surgical debridement)\n  * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and\u002For hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and\u002F or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary","18 Years",{"count":217,"type":21},104,[219],"NA","The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.",[222,223,224,225,226,227,27,228,229],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Pressure Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Traumatic Wounds","Surgical Wounds",[231,232],"Debridement","mechanical debridement","2025-12-17",{"date":235,"type":37},"2025-12-31",{"date":237,"type":37},"2025-05-09",{"date":239,"type":21},"2026-02",{"name":241,"class":44},"Lohmann & Rauscher",5]