[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545326":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":25,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":25,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Infectopharm Arzneimittel GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5% Permethrin Creme","ACTIVE_COMPARATOR","Permethrin Cream 5 % is the already approved standard therapeutic agent InfectoScab 5 % Cream, contains the active ingredient permethrin in a 5 % concentration and is used for the topical treatment of scabies. The cream is also used as a topical cream, e.g. after washing hands.",[13],"Drug: 5% Permethrin Creme",{"label":15,"type":16,"description":17,"interventionNames":18},"10% Permethrin Creme","EXPERIMENTAL","Permethrin Cream 10 % also contains the active ingredient permethrin, but in double the concentration, and otherwise corresponds to the approved standard therapeutic agent InfectoScab 5 % Cream in terms of the main other ingredients. This is also used for the topical treatment of scabies, as well as for re-creaming, e.g. after washing hands.",[19],"Drug: 10% Permethrin Creme",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","At visit V0, the investigational cream is applied once topically to the whole body. For patients who are not cured at visit V1, i.e. 14 days later, the application is repeated analogously once at this time.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Cord Sunderkötter, Prof. Dr.","Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Bertil Wachall, Dr.","CONTACT","06252 95 7000","clinical.trials@infectopharm.com",{"type":40,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[42],{"name":43,"class":6},"Winicker Norimed GmbH","100545326","phase-3-therapy-for-scabies-with-two-differently-concentrated-permethrin-creams-100545326",false,"NCT06380452","Therapy for Scabies With Two Differently Concentrated Permethrin Creams","Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.","SKABUP","Inclusion Criteria:\n\n* Confirmed acute scabies disease: Detection of mites and\u002For mite nymphs and\u002For mite larvae, by reflected light microscopy or light microscopy of skin samples, at scabies-typical predilection sites\n* Age between 2 years and 85 years\n* Written informed consent of the study participant (if of legal age) or all legal guardians (for underage study participants \\\u003C 12 years) or all legal guardians and the study participant (for underage study participants ≥ 12 years)\n* Practicable application of the trial medication by trained specialist staff at the trial site\n\nExclusion Criteria:\n\n* Pre-treatment with antiscabiosa in the last 14 days\n* Combined antiscabial treatment (i.e. simultaneous\u002Fsimultaneous topical and systemic scabies treatment with medication) in the last 3 months\n* Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication\n* Scabies crustosa\n* Impetiginization\u002Feczematization requiring inpatient treatment\n* Body weight \\> 120 kg\n* Pregnancy, breastfeeding\n* Clinically relevant immunodeficiency (of any kind, including extensive local therapy (\\>20% body surface) with corticosteroids \\> 2 weeks in the last 4 weeks or ≥ 10 mg prednisolone equivalent \\>7 days in the last 4 weeks - even without signs of scabies crustosa)\n* Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study\n* Planned systemic use of corticosteroids\n* Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants\n* Apparent unreliability or unwillingness to cooperate\n* Inability to understand and comply with study instructions\n* Known alcohol, medication or drug dependence\n* Placement in a facility where people live together for long periods of time, are cared for or receive medical care, and where close skin-to-skin contact is common, or placement in an institution ordered by a court\u002Fauthority\n* 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)\n* Close contact person who refuses scabies treatment or for whom treatment is not possible\n* Dependence on sponsor or investigator\n* Previous participation in a clinical trial in the last 30 days or in the same clinical trial","ALL","2 Years","85 Years",{"count":56,"type":57},220,"ESTIMATED","INTERVENTIONAL",[60],"PHASE3","The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.\n\nThe trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.",[63],"Scabies","NOT_YET_RECRUITING","2024-04-22",{"date":67,"type":68},"2024-04-23","ACTUAL",{"date":70,"type":57},"2024-05",{"date":72,"type":57},"2028-12",{"name":5,"class":6}]