[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Organon and Co\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100613353","phase-3-a-study-to-investigate-safety-and-efficacy-of-tapinarof-cream-1-in-participants-ages-3-months-to--24-months-with-atopic-dermatitis-100613353",false,"NCT07265479","A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to \u003C 24 Months With Atopic Dermatitis","A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to \u003C 24 Months With Atopic Dermatitis","Adoring","Inclusion Criteria:\n\n* Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \\\u003C24 months of age at the Screening visit.\n* Clinical diagnosis of atopic dermatitis (AD), AD covering \\>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4\n* Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities\n* Legal guardian or primary caregiver is able and willing to adhere to protocol requirements\n\nExclusion Criteria:\n\n* Significant neurological disorder or history of seizure\n* Know clinically significant cardiac rhythm or cardiac disorder\n* History of sudden infant death in a sibling\n* Clinically significant chromosome abnormality\n* History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation\n* Diseases that could cause pruritic and\u002For sleep disruption\n* Immunocompromised\n* Current chronic or acute infection requiring treatment\n* Use of prohibited medication(s) or procedure(s)\n* Use of prohibited medications by breastfeeding mother if breastfeeding participant","ALL","3 Months","23 Months",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.",[28],"Atopic Dermatitis",[30,31,32,33],"Pediatric Atopic Dermatitis","Eczema","tapinarof","topical","RECRUITING","2026-06-03",{"date":37,"type":38},"2026-06-04","ACTUAL",{"date":40,"type":38},"2025-12-29",{"date":42,"type":22},"2028-01",{"name":44,"class":45},"Organon and Co","INDUSTRY",47,""]