[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659032":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":68,"interventions":79,"overallOfficials":56,"centralContacts":87,"locations":93,"responsibleParty":110,"collaborators":56,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":56,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":56,"enrollmentInfo":121,"targetDuration":56,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":96,"whyStopped":56,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Energenesis Biomedical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Local Target Lesion Adverse Events","Number of local target lesion adverse events with onset during the specified assessment period.","Day 1 through Day 85",[14,17,21,25,29,33,36,40,43,47,50,53],{"measure":15,"description":16,"timeFrame":12},"Incidence of Adverse Events Excluding Local Target Lesion Adverse Events","Number of adverse events, excluding local target lesion adverse events, with onset during the specified assessment period.",{"measure":18,"description":19,"timeFrame":20},"Number of participants with abnormalities in vital signs","Vital signs measurement consist of systolic and diastolic blood pressure, respiratory rate, pulse rate, and body temperature.","Baseline to Days 15, 29, 43, 57, 71, and 85",{"measure":22,"description":23,"timeFrame":24},"Number of participants with abnormalities in laboratory examination results","Laboratory tests to be measured in this study will consist of the following:\n\n* Hematology: white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, platelets, red blood cells (RBC).\n* Biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin, direct bilirubin, glucose, HbA1c, serum creatinine, blood urea nitrogen (BUN), albumin, prealbumin, and estimated glomerular filtration rate (eGFR).\n* Urinalysis: chemical strip (specific gravity, pH, occult blood, leukocytes, glucose, protein, ketones, bilirubin.","Baseline to Days 57 and 85",{"measure":26,"description":27,"timeFrame":28},"Number of Subjects With Abnormal Physical Examination Findings","Number of subjects with abnormal physical examination findings at Day 57 and Day 85.","Day 57 and Day 85",{"measure":30,"description":31,"timeFrame":32},"Proportion of Target Lesions With Complete Lesion Closure","Proportion of target lesions with complete lesion closure as assessed by the investigator at each specified visit.","Days 15, 29, 43, and 57",{"measure":34,"description":35,"timeFrame":32},"Intra-Subject Comparison of Target Lesion Re-epithelialization","Intra-subject comparison of target lesions with respect to re-epithelialization as assessed by the investigator at each specified visit.",{"measure":37,"description":38,"timeFrame":39},"Net Change From Baseline in Target Lesion Size","Net change in target lesion size from baseline at each specified visit.","Baseline to Days 15, 29, 43, and 57",{"measure":41,"description":42,"timeFrame":39},"Percent Change From Baseline in Target Lesion Size","Percent change in target lesion size from baseline at each specified visit.",{"measure":44,"description":45,"timeFrame":46},"Time to First Target Lesion Closure","Time from baseline to the first occurrence of target lesion closure.","Baseline through Day 57",{"measure":48,"description":49,"timeFrame":32},"Proportion of Target Lesions With at Least 50% Lesion Closure","Proportion of target lesions achieving at least 50% lesion closure at each specified visit.",{"measure":51,"description":52,"timeFrame":32},"Proportion of Target Lesions With at Least 75% Lesion Closure","Proportion of target lesions achieving at least 75% lesion closure at each specified visit.",{"measure":54,"description":55,"timeFrame":46},"Proportion of Target Lesions With at Least One Complete Lesion Closure","Proportion of target lesions that achieved complete lesion closure at least once, as assessed by the investigator, at any assessment up to Visit 7, regardless of subsequent reopening.",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":63},"QUADRUPLE",[64,65,66,67],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[69,74],{"label":70,"type":71,"description":56,"interventionNames":72},"ENERGI-F703EB Cream","ACTIVE_COMPARATOR",[73],"Drug: ENERGI-F703EB Cream",{"label":75,"type":76,"description":56,"interventionNames":77},"Matched vehicle cream","PLACEBO_COMPARATOR",[78],"Drug: Matched vehicle cream",[80,84],{"type":81,"name":70,"description":82,"armGroupLabels":83,"otherNames":56},"DRUG","Standard of care and ENERGI-F703EB Cream is applied for the treatment of Epidermolysis Bullosa",[70],{"type":81,"name":75,"description":85,"armGroupLabels":86,"otherNames":56},"Standard of care and matched vehicle cream is applied for the treatment of Epidermolysis Bullosa",[75],[88],{"name":89,"role":90,"phone":91,"phoneExt":56,"email":92},"Yifang Cheng, PhD","CONTACT","+886-2-26270835","ct@energenesis-biomedical.com",[94],{"facility":95,"status":96,"city":97,"state":56,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"National Cheng Kung University Hospital","RECRUITING","Tainan","704","Taiwan","TW",{"type":102,"coordinates":103},"Point",[104,105],120.21333,22.99083,{"lat":105,"lon":104},[108],{"name":109,"role":90,"phone":56,"phoneExt":56,"email":56},"Hsu, Dr.",{"type":111,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100659032","phase-2-a-study-to-evaluate-energi-f703eb-cream-in-epidermolysis-bullosa-100659032",false,"NCT07858422","A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa","A Phase II Study Evaluating the Safety and Efficacy of ENERGI-F703EB Cream in Subjects With Epidermolysis Bullosa","Inclusion Criteria:\n\nA subject is eligible for the study if all of the following apply:\n\n1. With either gender aged ≥ 18 years old at the Screening Visit.\n2. Subject has clinical diagnosis and laboratory evidence of EB simplex, junctional EB, or dystrophic EB.\n\n   Note: Subjects may be included if diagnostic testing confirms subtype. Acceptable diagnostic testing methods include transmission electron microscopy and immunofluorescence studies.\n3. Potential target and target lesions can be located anywhere on the body except on or near the joints (e.g., the elbows and the ankle), face, scalp, groin, palms and soles.\n4. Potential target lesions have been present for ≥ 21 days and \\\u003C 9 months at the Screening Visit (Visit 1).\n5. Subject's target EB lesions in the matched target lesion pair fulfill all of the following criteria at the Baseline Visit (Visit 2):\n\n   1. The size of each lesion is between 10 - 40 cm2.\n   2. Each lesion did not exhibit ≥ 30% reduction in size compared to the measurement taken at the Screening Visit.\n   3. The two lesions have a size difference of ≤ 20%.\n   4. The two lesions are separated by ≥ 6 cm apart from each other.\n6. Subject is able and willing to follow study procedures and instructions.\n7. Subject has signed the written informed consent form.\n8. Male subjects must be surgically sterile or commit to the use of a highly effective method of contraception (See Appendix 1) for the duration of the study.\n9. Female subjects are eligible only if all of the following apply:\n\n   1. Not pregnant with a negative serum or urine pregnancy test at the Screening Visit and at Visit 2 before randomization (test not required for females of non-childbearing potential).\n   2. Not lactating.\n   3. Not planning to become pregnant during the study.\n   4. If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study (See Appendix 1 for acceptable methods of contraception).\n\nExclusion Criteria:\n\nA subject meeting any of the exclusion criteria will be excluded from study participation:\n\n1. Subject's target EB lesions in the matched target lesion pair fulfill any of the following criteria:\n\n   1. Have clinical signs of infection as evidenced by ongoing adverse event and\u002For use of topical antibiotics within 14 days prior to Visit 2.\n   2. Use of topical steroidal therapy within 28 days prior to Visit 2.\n   3. Use of topical silver products (e.g. silver sulfadiazine cream, colloidal silver) within 14 days prior to Visit 2.\n2. Use of systemic steroidal therapy within 28 days prior to Visit 2 (Except for inhaled, ophthalmic, or for systemic manifestations of EB per investigator's discretion).\n3. Subject has a current or history of malignancy within 2 years prior to Visit 2.\n4. Use of any other investigational drug within 28 days prior to the Screening Visit.\n5. With known or suspected hypersensitivity to any ingredients in ENERGI-F703EB Cream or matched vehicle cream.\n6. With any of the following impaired hepatic or renal functions at the Screening Visit:\n\n   1. ALT or AST \\> 2× ULN\n   2. Total bilirubin \\> 1.5× ULN\n   3. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n\n   Note: For eGFR, the CKD-EPI creatinine equation (2021) will be used: eGFR (mL\u002Fmin\u002F1.73 m2) = 142 × min (SCr\u002FK, 1)α × max (SCr\u002FK, 1)-1.200 × 0.9938age × (1.012 if female); where:\n   * SCr = serum creatinine (mg\u002FdL)\n   * K = 0.7 (females) or 0.9 (males)\n   * α = -0.241 (females) or -0.302 (males)\n   * min = indicates minimum of SCr\u002FK or 1\n   * max = indicates maximum of SCr \u002FK or 1\n7. With any condition judged by the investigator that entering the trial may be detrimental to the subject.","ALL","18 Years",{"count":122,"type":123},24,"ESTIMATED","INTERVENTIONAL",[126],"PHASE2","This is a phase II, intra-subject randomized, double-blind, vehicle-controlled, parallel, multicenter study to evaluate the safety and preliminary efficacy of ENERGI-F703EB Cream in subjects who are ≥ 18 years old with epidermolysis bullosa simplex (EBS), junctional epidermolysis bullosa (JEB), or dystrophic epidermolysis bullosa (DEB). In total, approximately 24 subjects will be enrolled from multiple sites in Taiwan. The study duration per subject is approximately 16 weeks; which includes a 2 to 4-week period between Visit 1 and Visit 2 for screening, an 8-week period from Visit 2 to Visit 7 for treatment, and a 4-week period from Visit 7 to Visit 9 for safety follow-up.",[129,130,131,132],"Epidermolysis Bullosa (EB)","Junctional Epidermolysis Bullosa","Epidermolysis Bullosa Simplex","Dystrophic Epidermolysis Bullosa",[134,135],"Epidermolysis Bullosa","EB","2026-10-01",{"date":138,"type":139},"2026-10-05","ACTUAL",{"date":141,"type":123},"2026-10-08",{"date":143,"type":123},"2027-06-15",{"name":5,"class":6},1]