[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07265479":3,"trial-entities:NCT07265479":467,"trial-summary:NCT07265479":470},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":51,"secondary_outcomes":60,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":109,"locations":111,"central_contacts":460,"overall_officials":461,"references":465,"see_also_links":466},"NCT07265479","OG0505-3104","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","ACTIVE_NOT_RECRUITING","2027-08","2026-08","2026-08-12","2025-12-29","Organon and Co","INDUSTRY",false,"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.",null,[19],"Atopic Dermatitis",[21,22,23,24],"Pediatric Atopic Dermatitis","Eczema","tapinarof","topical","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},187,"ACTUAL",[33,46],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Tapinarof cream, 1%","Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.",[38],"Tapinarof cream",[40,41,42,43,44,45],"OG-0505","DMVT-505","GSK2894512A","GSK28994512","STI-1001","WBI-1001",{"type":34,"name":47,"description":48,"armGroupLabels":49},"Vehicle Cream","Applied topically once daily to lesions on participant's skin during the Double-Blind period.",[50],"Vehicle cream",[52,56],{"measure":53,"description":54,"timeFrame":55},"Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8","The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration\u002Fpapulation, lichenification, oozing\u002Fcrusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.","Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.",{"measure":57,"description":58,"timeFrame":59},"Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period","The vIGA-AD is a clinical tool for assessing the current state\u002Fseverity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration\u002Fpapulation, lichenification, oozing\u002Fcrusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.","Baseline to the end of the Open-Label Period, up to 56 weeks.",[61,64,67,70,74,76,79,80,83,85,87],{"measure":62,"description":63,"timeFrame":55},"Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.","The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema\u002Fpapulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease.",{"measure":65,"description":66,"timeFrame":55},"Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8","Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \\[10 handprints\\], upper extremities = 20% \\[20 handprints\\], trunk (including axillae and groin) = 30% \\[30 handprints\\], lower extremities, including buttocks, = 40% \\[40 handprints\\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.",{"measure":68,"description":69,"timeFrame":55},"Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8","Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema\u002Fpapulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.",{"measure":71,"description":72,"timeFrame":73},"Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)","TEAEs are AEs that started on or after the first dose of study medication.","Baseline to last planned visit in the Double-Blind Period, up to 8 weeks",{"measure":71,"description":72,"timeFrame":75},"Baseline to the end of the Open-Label Period, up to 56 weeks",{"measure":77,"description":72,"timeFrame":78},"Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)","Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .",{"measure":77,"description":72,"timeFrame":59},{"measure":81,"description":82,"timeFrame":73},"Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)","The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.",{"measure":81,"description":82,"timeFrame":84},"Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.",{"measure":86,"description":82,"timeFrame":73},"Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)",{"measure":86,"description":82,"timeFrame":84},"ALL","3 Months","23 Months",{"inclusion":92,"exclusion":97,"raw_text":108},[93,94,95,96],"Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \\\u003C24 months of age at the Screening visit.","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","Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities","Legal guardian or primary caregiver is able and willing to adhere to protocol requirements",[98,99,100,101,102,103,104,105,106,107],"Significant neurological disorder or history of seizure","Know clinically significant cardiac rhythm or cardiac disorder","History of sudden infant death in a sibling","Clinically significant chromosome abnormality","History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation","Diseases that could cause pruritic and\u002For sleep disruption","Immunocompromised","Current chronic or acute infection requiring treatment","Use of prohibited medication(s) or procedure(s)","Use of prohibited medications by breastfeeding mother if breastfeeding participant","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",[110],"CHILD",[112,121,129,137,144,151,158,166,174,181,188,196,204,212,220,227,235,243,251,259,267,275,283,291,296,302,310,318,326,334,338,346,353,361,368,375,383,392,399,407,415,423,431,438,445,453],{"facility":113,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"AllerVie Clinical Research","Birmingham","Alabama","35209","United States",{"lat":119,"lon":120},33.52066,-86.80249,{"facility":122,"city":123,"state":124,"zip":125,"country":117,"geoPoint":126},"Dermatology Trial Associates","Bryant","Arkansas","72022",{"lat":127,"lon":128},34.59593,-92.48905,{"facility":130,"city":131,"state":132,"zip":133,"country":117,"geoPoint":134},"Dermatology Research Associates","Los Angeles","California","90045",{"lat":135,"lon":136},34.05223,-118.24368,{"facility":138,"city":139,"state":132,"zip":140,"country":117,"geoPoint":141},"Integrative Skin Science and Research","Sacramento","95815",{"lat":142,"lon":143},38.58157,-121.4944,{"facility":145,"city":146,"state":132,"zip":147,"country":117,"geoPoint":148},"Allergy and Asthma Medical Group and Research Center","San Diego","92123",{"lat":149,"lon":150},32.71571,-117.16472,{"facility":152,"city":153,"state":132,"zip":154,"country":117,"geoPoint":155},"Clinical Trials Research Institute","Thousand Oaks","91320",{"lat":156,"lon":157},34.17056,-118.83759,{"facility":159,"city":160,"state":161,"zip":162,"country":117,"geoPoint":163},"Clarity Dermatology","Castle Rock","Colorado","80109",{"lat":164,"lon":165},39.37221,-104.85609,{"facility":167,"city":168,"state":169,"zip":170,"country":117,"geoPoint":171},"Skin Care Research, LLC.","Boca Raton","Florida","33486",{"lat":172,"lon":173},26.35869,-80.0831,{"facility":175,"city":176,"state":169,"zip":177,"country":117,"geoPoint":178},"APEX Clinical Trials","Jacksonville","32256",{"lat":179,"lon":180},30.33218,-81.65565,{"facility":182,"city":183,"state":169,"zip":184,"country":117,"geoPoint":185},"TruDerm Research","Wellington","33449",{"lat":186,"lon":187},26.65868,-80.24144,{"facility":189,"city":190,"state":191,"zip":192,"country":117,"geoPoint":193},"Cleaver Medical Group Dermatology, Inc","Cumming","Georgia","30040",{"lat":194,"lon":195},34.20732,-84.14019,{"facility":197,"city":198,"state":199,"zip":200,"country":117,"geoPoint":201},"Ada West Research","Meridian","Idaho","83646",{"lat":202,"lon":203},43.61211,-116.39151,{"facility":205,"city":206,"state":207,"zip":208,"country":117,"geoPoint":209},"Endeavor Health Clinical Trials Center","Skokie","Illinois","60077",{"lat":210,"lon":211},42.03336,-87.73339,{"facility":213,"city":214,"state":215,"zip":216,"country":117,"geoPoint":217},"Dawes Fretzin Clinical Research Group, LLC","Indianapolis","Indiana","46250",{"lat":218,"lon":219},39.76838,-86.15804,{"facility":221,"city":222,"state":215,"zip":223,"country":117,"geoPoint":224},"The Indiana Clinical Trials Center, PC","Plainfield","46168",{"lat":225,"lon":226},39.70421,-86.39944,{"facility":228,"city":229,"state":230,"zip":231,"country":117,"geoPoint":232},"Equity Medical, LLC","Bowling Green","Kentucky","42104",{"lat":233,"lon":234},36.99032,-86.4436,{"facility":236,"city":237,"state":238,"zip":239,"country":117,"geoPoint":240},"Lawrence J Green, MD LLC","Rockville","Maryland","20850",{"lat":241,"lon":242},39.084,-77.15276,{"facility":244,"city":245,"state":246,"zip":247,"country":117,"geoPoint":248},"Oakland Hills Dermatology","Auburn Hills","Michigan","48326",{"lat":249,"lon":250},42.68753,-83.2341,{"facility":252,"city":253,"state":254,"zip":255,"country":117,"geoPoint":256},"Minnesota Clinical Study Center","New Brighton","Minnesota","55112",{"lat":257,"lon":258},45.06552,-93.20189,{"facility":260,"city":261,"state":262,"zip":263,"country":117,"geoPoint":264},"SKY Integrative Medical Center","Ridgeland","Mississippi","39157",{"lat":265,"lon":266},32.42848,-90.13231,{"facility":268,"city":269,"state":270,"zip":271,"country":117,"geoPoint":272},"MediSearch Clinical Trials","Saint Joseph","Missouri","64506",{"lat":273,"lon":274},39.76861,-94.84663,{"facility":276,"city":277,"state":278,"zip":279,"country":117,"geoPoint":280},"Skin Cancer and Dermatology Institute","Reno","Nevada","89509",{"lat":281,"lon":282},39.52963,-119.8138,{"facility":284,"city":285,"state":286,"zip":287,"country":117,"geoPoint":288},"Forest Hills Dermatology Group","Kew Gardens","New York","11415",{"lat":289,"lon":290},40.71427,-73.83097,{"facility":292,"city":286,"state":286,"zip":293,"country":117,"geoPoint":294},"Bobby Buka MD, PC","10012",{"lat":289,"lon":295},-74.00597,{"facility":228,"city":297,"state":286,"zip":298,"country":117,"geoPoint":299},"The Bronx","10455",{"lat":300,"lon":301},40.84985,-73.86641,{"facility":303,"city":304,"state":305,"zip":306,"country":117,"geoPoint":307},"The University of North Carolina Dermatology and Skin Cancer Center","Chapel Hill","North Carolina","27516",{"lat":308,"lon":309},35.9132,-79.05584,{"facility":311,"city":312,"state":313,"zip":314,"country":117,"geoPoint":315},"Dermatologists of Central States, LLC","Fairborn","Ohio","45324",{"lat":316,"lon":317},39.82089,-84.01938,{"facility":319,"city":320,"state":321,"zip":322,"country":117,"geoPoint":323},"Allergy Asthma and Clinical Research Center","Oklahoma City","Oklahoma","73120",{"lat":324,"lon":325},35.46756,-97.51643,{"facility":327,"city":328,"state":329,"zip":330,"country":117,"geoPoint":331},"Oregon Dermatology and Research Center","Portland","Oregon","97210",{"lat":332,"lon":333},45.52345,-122.67621,{"facility":335,"city":328,"state":329,"zip":336,"country":117,"geoPoint":337},"Oregon Health & Science University","97239",{"lat":332,"lon":333},{"facility":339,"city":340,"state":341,"zip":342,"country":117,"geoPoint":343},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":344,"lon":345},32.77632,-79.93275,{"facility":347,"city":348,"state":341,"zip":349,"country":117,"geoPoint":350},"National Allergy and Asthma Research, LLC.","North Charleston","29420",{"lat":351,"lon":352},32.85462,-79.97481,{"facility":354,"city":355,"state":356,"zip":357,"country":117,"geoPoint":358},"The University of Texas Health Science Center at Houston","Bellaire","Texas","77401",{"lat":359,"lon":360},29.70579,-95.45883,{"facility":362,"city":363,"state":356,"zip":364,"country":117,"geoPoint":365},"Dermatology Treatment and Research Center","Dallas","75230",{"lat":366,"lon":367},32.78306,-96.80667,{"facility":369,"city":370,"state":356,"zip":371,"country":117,"geoPoint":372},"Stryde Research - Epiphany Dermatology","Southlake","76092",{"lat":373,"lon":374},32.94124,-97.13418,{"facility":376,"city":377,"state":378,"zip":379,"country":117,"geoPoint":380},"Dermatology Specialists of Spokane","Spokane","Washington","99202",{"lat":381,"lon":382},47.65966,-117.42908,{"facility":384,"city":385,"state":386,"zip":387,"country":388,"geoPoint":389},"Dermatology Research Institute","Calgary","Alberta","T2J 7E1","Canada",{"lat":390,"lon":391},51.05011,-114.08529,{"facility":393,"city":394,"state":386,"zip":395,"country":388,"geoPoint":396},"CARe Clinic (Central Alberta Research Clinic)","Red Deer","T4P 1K4",{"lat":397,"lon":398},52.26682,-113.802,{"facility":400,"city":401,"state":402,"zip":403,"country":388,"geoPoint":404},"Dr. Chih-Ho Hong Medical Inc.","Surrey","British Columbia","V3R 6A7",{"lat":405,"lon":406},49.10635,-122.82509,{"facility":408,"city":409,"state":410,"zip":411,"country":388,"geoPoint":412},"Manitoba Allergy Research Inc.","Winnipeg","Manitoba","R3J 0S9",{"lat":413,"lon":414},49.8844,-97.14704,{"facility":416,"city":417,"state":418,"zip":419,"country":388,"geoPoint":420},"Maritime Dermatology","Halifax","Nova Scotia","B3K 5R3",{"lat":421,"lon":422},44.64269,-63.57688,{"facility":424,"city":425,"state":426,"zip":427,"country":388,"geoPoint":428},"Halton Pediatric Allergy","Burlington","Ontario","L7L 6W6",{"lat":429,"lon":430},43.38621,-79.83713,{"facility":432,"city":433,"state":426,"zip":434,"country":388,"geoPoint":435},"Triple A Lab Inc.","Hamilton","L8S 1G5",{"lat":436,"lon":437},43.25011,-79.84963,{"facility":439,"city":440,"state":426,"zip":441,"country":388,"geoPoint":442},"Allergy Research Canada Inc.","Niagara Falls","L2H 1C4",{"lat":443,"lon":444},43.10012,-79.06627,{"facility":446,"city":447,"state":448,"zip":449,"country":388,"geoPoint":450},"Dr. Rachel Asiniwasis Medical Professional Corporation","Regina","Saskatchewan","S4V 1R9",{"lat":451,"lon":452},50.45008,-104.6178,{"facility":454,"city":455,"state":448,"zip":456,"country":388,"geoPoint":457},"Skinsense Medical Research","Saskatoon","S7K 2C1",{"lat":458,"lon":459},52.13238,-106.66892,[],[462],{"name":463,"affiliation":13,"role":464},"Clinical Lead Late-Stage Clinical Development","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":468,"biomarkers":469},[19],[],{"nct_id":4,"found":471,"summary":472,"prompt_version":482},true,{"design":473,"status":474,"heading":475,"summary":476,"follow_up":477,"word_count":478,"commitments":479,"compensation":480,"drugs_mentioned":481},"This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 3 study and plans to enroll 180 participants.","completed","Study of Tapinarof Cream for Atopic Dermatitis in Infants and Toddlers","This study is looking at how safe and effective Tapinarof cream, 1% is for infants and toddlers aged 3 months to less than 24 months who have atopic dermatitis (eczema). Participants will apply either Tapinarof cream or a vehicle cream (a cream without the active medicine) to their skin once daily. The study aims to see if Tapinarof cream can help clear up eczema or significantly improve it. To join, your child must be between 3 and 23 months old, have a diagnosis of atopic dermatitis covering more than 5% of their body, and have a certain severity of eczema. The study plans to enroll 180 participants, but its current status is unclear.","Participants will be followed for up to 56 weeks to assess the cream's effectiveness.",113,"Participants will apply cream to their skin once daily during the double-blind period, and then as needed during the open-label period. The double-blind period lasts up to 8 weeks, and the open-label period lasts up to 56 weeks.","Not stated in the trial record.",[35,47],"v2"]