[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607137":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":49,"collaborators":11,"id":51,"slug":11,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OPA-15406 foam","EXPERIMENTAL",null,[13],"Drug: OPA-15406",{"label":15,"type":10,"description":11,"interventionNames":16},"Vehicle",[17],"Drug: Vehicle",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","OPA-15406","0.3% foam or 1% foam, topical, twice daily, for 8 weeks",[9],[25],"difamilast",{"type":20,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"vehicle, topical, twice daily, for 8 weeks",[15],[30],{"name":31,"affiliation":5,"role":32},"Nobuhito Sanada","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":11},"Drug Information Center","CONTACT","+81-3-6361-7314",[39],{"facility":40,"status":11,"city":41,"state":11,"zip":11,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Sumire Dermatology Clinic","Tokyo","Japan",{"type":44,"coordinates":45},"Point",[46,47],139.69171,35.6895,{"lat":47,"lon":46},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607137",false,"NCT07184645","A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)","Inclusion Criteria:\n\n* Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)\n* Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations\n* Participants with an IGA score of 2 or 3 at the screening and baseline examinations\n\nExclusion Criteria:\n\n* Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination\n* Participants who have been treated with OPA-15406 ointment in the past","ALL","3 Months","14 Years",{"count":61,"type":62},198,"ESTIMATED","INTERVENTIONAL",[65],"PHASE3","To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)",[68],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2025-09-18",{"date":72,"type":73},"2025-09-22","ACTUAL",{"date":75,"type":62},"2025-09",{"date":77,"type":62},"2027-02",{"name":5,"class":6},1]