[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606278":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":35,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":67,"collaborators":13,"id":69,"slug":13,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":13,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":13,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":13,"overallStatus":87,"whyStopped":13,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Success rate in Investigator's Global Assessment (IGA)","The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe\u002Fvery severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.","Week 4",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,31],{"label":27,"type":28,"description":13,"interventionNames":29},"1% OPA-15406 foam","EXPERIMENTAL",[30],"Drug: OPA-15406",{"label":32,"type":28,"description":13,"interventionNames":33},"Vehicle",[34],"Drug: Vehicle",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","OPA-15406","1% foam, topical, twice daily, for 4 weeks",[27],[42],"difamilast",{"type":37,"name":32,"description":44,"armGroupLabels":45,"otherNames":13},"vehicle, topical, twice daily, for 4 weeks",[32],[47],{"name":48,"affiliation":5,"role":49},"Nobuhito Sanada","STUDY_DIRECTOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":13},"Drug Information Center","CONTACT","+81-3-6361-7314",[56],{"facility":57,"status":13,"city":58,"state":13,"zip":13,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":13},"Mita Dermatology Clinic","Tokyo","Japan","JP",{"type":62,"coordinates":63},"Point",[64,65],139.69171,35.6895,{"lat":65,"lon":64},{"type":68,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100606278",false,"NCT07173478","A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)","Inclusion Criteria:\n\n* Participants who have been diagnosed AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)\n* Participants with a history of AD for at least 3 years\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","15 Years","70 Years",{"count":79,"type":80},156,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).",[86],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2025-09-07",{"date":90,"type":91},"2025-09-15","ACTUAL",{"date":93,"type":80},"2025-10",{"date":95,"type":80},"2026-12",{"name":5,"class":6},1]