[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597290":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":79,"collaborators":20,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":20,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Biokosmes Srl","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"047_TD Dermatitis cream","EXPERIMENTAL","047\\_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.",[13],"Device: 047_TD Dermatitis cream twice a day for 28 days",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","047_TD Dermatitis cream twice a day for 28 days","047\\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Donatella Mariani","CONTACT","+41 79 844 2600","ssu@solarishc.ch",[28,48,64],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Studio Medico Pigatto Bersani","NOT_YET_RECRUITING","Milan","20154","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.59836,42.78235,{"lat":39,"lon":38},[42,46],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Paolo Pigatto, Professor","+39 348 704250","pigatto@pigattobersani.it",{"name":43,"role":47,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":49,"status":50,"city":51,"state":20,"zip":52,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Poliambulatorio Verona","RECRUITING","Verona","37135",{"type":36,"coordinates":54},[55,56],10.9938,45.43854,{"lat":56,"lon":55},[59,63],{"name":60,"role":24,"phone":61,"phoneExt":20,"email":62},"Giampiero Girolomoni, Professor","+39 045 8122547","giampiero.girolomoni@univr.it",{"name":60,"role":47,"phone":20,"phoneExt":20,"email":20},{"facility":65,"status":30,"city":66,"state":20,"zip":67,"country":33,"countryCode":34,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Studio Medico","Voghera","27058",{"type":36,"coordinates":69},[70,71],9.01175,44.99151,{"lat":71,"lon":70},[74,78],{"name":75,"role":24,"phone":76,"phoneExt":20,"email":77},"Michela Quaglini, Dr.","+39 335 563792","m_quaglini@libero.it",{"name":75,"role":47,"phone":20,"phoneExt":20,"email":20},{"type":80,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100597290","post-marketing-clinical-follow-up-trial-to-evaluate-the-performance-and-safety-of-the-medical-device-047-td-dermatitis-cream-in-adults-and-children-with-atopic-and-contact-dermatitis-symptoms-confirmed-by-clinical-parameters-100597290",false,"NCT07056569","Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters","Inclusion Criteria:\n\n1. Male\u002F female \\> 6 months \\\u003C 65 years\n2. Patient diagnosed AD\u002FCD\n3. Patient with EASI max \\\u003C16\n4. Patient with IGA 1-3\n5. Patient in good condition with no serious systemic disease\n\nExclusion Criteria:\n\n1. Hypersensitivity to any 047\\_TD Dermatitis cream ingredients\n2. Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator\n3. Any other adjuvant therapy for AD\u002FCD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study\n4. Any use of another topical emollient or other established treatment for AD\u002FCD during the study at the site of flares (AD\u002FCD lesions). Exception are usual hygienic products in the diaper area\n5. A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy\n6. Drug abuser\n7. Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old\n8. Could not provide written informed consent or parents' informed consent to have their child participate in the study","ALL","6 Months","65 Years",{"count":91,"type":92},90,"ESTIMATED","INTERVENTIONAL",[95],"NA","The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.",[98,99,100,101,102],"Dermatitis, Contact","Dermatitis","Dermatitis, Chronic","Dermatitis, Eczematous","Dermatitis, Atopic Dermatitis",[99,104,105,106],"Atopic dermatitis","Contact dermatitis","Eczematous dermatitis","2025-06-30",{"date":109,"type":110},"2025-07-09","ACTUAL",{"date":112,"type":110},"2025-06-05",{"date":114,"type":92},"2025-09",{"name":5,"class":6},3]