[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316097":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":45,"centralContacts":32,"locations":49,"responsibleParty":180,"collaborators":32,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":32,"eligibilityCriteria":187,"healthyVolunteers":184,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":32,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":32,"overallStatus":200,"whyStopped":201,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"LEO Pharma","INDUSTRY",[8,14,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Fucicort® Lipid cream","EXPERIMENTAL","Fucicort® Lipid cream is a combination of the antibiotic fusidic acid (20 mg\u002Fg) and the corticosteroid betamethasone (1 mg\u002Fg (as 17-valerate)). Twice daily for two weeks.",[13],"Drug: Fucicort® Lipid cream",{"label":15,"type":16,"description":17,"interventionNames":18},"Fucidin cream +betamethasone cream","ACTIVE_COMPARATOR","The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.",[19,20],"Drug: Fucidin® cream","Drug: betamethasone (Lianbang Beisong®) cream",{"label":22,"type":23,"description":24,"interventionNames":25},"Vehicle cream","PLACEBO_COMPARATOR","The vehicle cream, also named as Fucicort® Lipid cream vehicle, is the identical cream of Fucicort Lipid cream but without the active ingredient. Twice daily for two weeks.",[26],"Drug: Fucicort® Lipid cream vehicle",[28,33,37,41],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.",[9],null,{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Fucidin® cream","The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.",[15],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Fucicort® Lipid cream vehicle","The active ingredient of Fucicort® Lipid cream vehicle is the identical cream of Fucicort® Lipid cream but without the active ingredient. The pack size of Fucicort® Lipid cream vehicle is 15g.",[22],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"betamethasone (Lianbang Beisong®) cream","The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.",[15],[46],{"name":47,"affiliation":5,"role":48},"Study Director","STUDY_DIRECTOR",[50,63,69,78,88,98,107,117,123,132,138,148,158,168,174],{"facility":51,"status":32,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":32},"Beijing Children's Hospital, Capital Medical University","Beijing","Beijing Municipality","100045","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},{"facility":64,"status":32,"city":52,"state":53,"zip":65,"country":55,"countryCode":56,"cosmosGeoPoint":66,"geoPoint":68,"contacts":32},"Peking Union Medical College Hospital","100730",{"type":58,"coordinates":67},[60,61],{"lat":61,"lon":60},{"facility":70,"status":32,"city":71,"state":71,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":32},"Guangdong General Hospital","Guangzhou","510080",{"type":58,"coordinates":74},[75,76],113.25,23.11667,{"lat":76,"lon":75},{"facility":79,"status":32,"city":80,"state":81,"zip":82,"country":55,"countryCode":56,"cosmosGeoPoint":83,"geoPoint":87,"contacts":32},"Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology","Wuhan","Hubei","430030",{"type":58,"coordinates":84},[85,86],114.26667,30.58333,{"lat":86,"lon":85},{"facility":89,"status":32,"city":90,"state":91,"zip":92,"country":55,"countryCode":56,"cosmosGeoPoint":93,"geoPoint":97,"contacts":32},"Dermatology Hospital, China Academy of Medicine and Science","Nanjing","Jiangsu","210042",{"type":58,"coordinates":94},[95,96],118.77778,32.06167,{"lat":96,"lon":95},{"facility":99,"status":32,"city":100,"state":91,"zip":101,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":32},"The First Affiliated Hospital of Soochow University","Suzhou","215006",{"type":58,"coordinates":103},[104,105],120.59538,31.30408,{"lat":105,"lon":104},{"facility":108,"status":32,"city":109,"state":110,"zip":111,"country":55,"countryCode":56,"cosmosGeoPoint":112,"geoPoint":116,"contacts":32},"The First Hospital of Dalian Medical University","Dalian","Liaoning","116011",{"type":58,"coordinates":113},[114,115],121.60222,38.91222,{"lat":115,"lon":114},{"facility":118,"status":32,"city":109,"state":110,"zip":119,"country":55,"countryCode":56,"cosmosGeoPoint":120,"geoPoint":122,"contacts":32},"The Second Hospital of Dalian Medical University","116023",{"type":58,"coordinates":121},[114,115],{"lat":115,"lon":114},{"facility":124,"status":32,"city":125,"state":110,"zip":126,"country":55,"countryCode":56,"cosmosGeoPoint":127,"geoPoint":131,"contacts":32},"The Chinese People's Liberation Army General Hospital Of Northern Theater","Shenyang","110000",{"type":58,"coordinates":128},[129,130],123.43278,41.79222,{"lat":130,"lon":129},{"facility":133,"status":32,"city":125,"state":110,"zip":134,"country":55,"countryCode":56,"cosmosGeoPoint":135,"geoPoint":137,"contacts":32},"The People's Hospital of Liaoning Province","110016",{"type":58,"coordinates":136},[129,130],{"lat":130,"lon":129},{"facility":139,"status":32,"city":140,"state":141,"zip":142,"country":55,"countryCode":56,"cosmosGeoPoint":143,"geoPoint":147,"contacts":32},"Tangdu Hospital","Xi'an","Shan'xi","710038",{"type":58,"coordinates":144},[145,146],108.92861,34.25833,{"lat":146,"lon":145},{"facility":149,"status":32,"city":150,"state":151,"zip":152,"country":55,"countryCode":56,"cosmosGeoPoint":153,"geoPoint":157,"contacts":32},"The Affiliated Hospital of Qingdao University","Qingdao","Shandong","266000",{"type":58,"coordinates":154},[155,156],120.38042,36.06488,{"lat":156,"lon":155},{"facility":159,"status":32,"city":160,"state":161,"zip":162,"country":55,"countryCode":56,"cosmosGeoPoint":163,"geoPoint":167,"contacts":32},"Shanghai Huashan Hospital","Shanghai","Shanghai Municipality","200040",{"type":58,"coordinates":164},[165,166],121.45806,31.22222,{"lat":166,"lon":165},{"facility":169,"status":32,"city":160,"state":161,"zip":170,"country":55,"countryCode":56,"cosmosGeoPoint":171,"geoPoint":173,"contacts":32},"Children's Hospital of Shanghai","200062",{"type":58,"coordinates":172},[165,166],{"lat":166,"lon":165},{"facility":175,"status":32,"city":52,"state":32,"zip":176,"country":55,"countryCode":56,"cosmosGeoPoint":177,"geoPoint":179,"contacts":32},"Children's Hospital, Capital Institute of Pediatrics","100020",{"type":58,"coordinates":178},[60,61],{"lat":61,"lon":60},{"type":181,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100316097","phase-3-efficacy-and-safety-of-fucicort-lipid-cream-compared-to-combination-treatment-with-fucidin-cream-followed-by-betamethasone-lianbang-beisong-cream-and-fucicort-lipid-cream-vehicle-in-clinically-infected-atopic-dermatitiseczema-100316097",false,"NCT03395132","Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis\u002FEczema","Inclusion Criteria:\n\n* Diagnosis of AD\u002Feczema as defined by Williams's criteria with clinical signs of infected AD\u002Feczema on trunk and\u002For extremities such as fluid drainage, blistered skin, white or yellow pus, severe itchiness and new burning sensation\n* A minimum score of 1 for each of the signs in the m-EASI score in at least one of the pre-defined body areas (trunk and\u002For extremities)\n* Subjects between 2 and 65 years of age\n\nExclusion Criteria:\n\n* History of concurrent diseases that could interfere with trial assessments or pose a safety concern\n* Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation on the treatment area that could interfere with assessments\n* Clinical findings such as severe heart, liver, kidney and lung deficiency, which will be impacted by the trial procedures at the investigator's discretion\n* Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation at investigator's discretion\n* Use of prohibited medication, i.e.\n\n  1. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation\n  2. Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation\n  3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation\n  4. Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation\n  5. Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation\n  6. Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation\n  7. The use of analgesics at the discretion of the investigator is allowed before and during the trial","ALL","2 Years","65 Years",{"count":192,"type":193},68,"ACTUAL","INTERVENTIONAL",[196],"PHASE3","The trial is designed to compare the efficacy and safety of Fucicort® Lipid cream with the combination treatment of Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, when applied twice daily for two weeks. The trial is designed to demonstrate that treatment with Fucicort® Lipid cream is not inferior to the combination treatment with the mono component drugs, Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream and that treatment with Fucicort® Lipid cream is superior to the treatment with Fucicort® Lipid cream vehicle. This is a 3-arm, parallel group, active- and vehicle-controlled trial comparing the efficacy and safety after 14 days treatment of Fucicort® Lipid cream, to Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, in subjects with clinically infected AD\u002Feczema.",[199],"Infected Atopic Dermatitis\u002FEczema","TERMINATED","Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.","2025-02-21",{"date":204,"type":193},"2025-02-24",{"date":206,"type":193},"2018-07-31",{"date":208,"type":193},"2019-05-09",{"name":5,"class":6},15]