[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06238765":3,"trial-entities:NCT06238765":108,"trial-summary:NCT06238765":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":86,"locations":88,"central_contacts":104,"overall_officials":105,"references":106,"see_also_links":107},"NCT06238765","CorEvitas-AD-555","CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry","RECRUITING","2099-12-31","2026-06","2026-06-29","2023-12-02","CorEvitas","NETWORK",false,"Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.","The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.\n\nThis provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.",[18],"Atopic Dermatitis",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1500,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"AD epidemiology, presentation, natural history, management, and outcomes","The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.","Through Study completion until the subject is 18 years",[33,36,40,43,45,48,51,54,57,59,61,63,65,67,69,71,73],{"measure":34,"timeFrame":35},"Percentage of patients with history of comorbidities","Time Frame: at registry enrollment",{"measure":37,"description":38,"timeFrame":39},"Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD","Score: 0-4, with high score indicating widespread of atopic dermatitis","every 6 months until the subject is 18 years",{"measure":41,"description":42,"timeFrame":39},"Physician reported: Nail changes due to atopic dermatitis (graduated VAS)","Scale - 0 (Clear\u002FNormal) to 100 (Severe Abnormalities). Lower numbers are for mild abnormalities in a few nails, higher numbers are for more severe changes in many nails",{"measure":44,"timeFrame":39},"Atopic dermatitis body surface area (BSA)",{"measure":46,"description":47,"timeFrame":39},"Eczema Area and Severity Index (EASI) (calculated)","The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.",{"measure":49,"description":50,"timeFrame":39},"Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)","The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe. For the Overall Score \\[SCORAD\\], select a lesion that that is representative of the body and score using the same severity scale",{"measure":52,"description":53,"timeFrame":39},"Patient reported : Patient global assessments of disease control and severity","This determines the progression \\& severity of the disease",{"measure":55,"timeFrame":56},"Physician reported : Pubertal Progression: Tanner Staging Assessment","Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment",{"measure":58,"timeFrame":39},"Patient reported: Patient Oriented Eczema Measure (POEM)",{"measure":60,"timeFrame":39},"Patient reported: Peak pruritus (itch) NRS",{"measure":62,"timeFrame":39},"Patient reported: Skin pain NRS",{"measure":64,"timeFrame":39},"Patient reported: Fatigue NRS",{"measure":66,"timeFrame":39},"Patient reported: Children's Dermatology Life Quality Index (CDLQI)",{"measure":68,"timeFrame":39},"Patient reported: Patient Health Questionnaire (PHQ-4)",{"measure":70,"timeFrame":39},"Patient reported: Atopic dermatitis control tool (ADCT)",{"measure":72,"timeFrame":39},"Patient reported: Asthma Control test",{"measure":74,"timeFrame":75},"Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)","6 months until the subject is 18 years","ALL","10 Years","15 Years",true,{"inclusion":81,"exclusion":83,"raw_text":85},[82],"To be eligible to participate in this registry, an individual must meet all the following criteria:",[84],"An individual who meets any of the following criteria will be excluded from participation in the registry:","Inclusion Criteria:\n\n* To be eligible to participate in this registry, an individual must meet all the following criteria:\n\n  1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider\n  2. Is 10 - 15 years of age at the time of enrollment.\n  3. Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment\n\n     Exclusion Criteria:\n* An individual who meets any of the following criteria will be excluded from participation in the registry:\n\n  1. Is participating or planning to participate in a blinded clinical trial for an AD drug.\n  2. Is unwilling or unable to provide standing height measurements.",[87],"CHILD",[89],{"facility":90,"status":7,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"CorEvitas, LLC","Waltham","Massachusetts","02451","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Cathy Cheney","CONTACT","508-555-1212","corevitasregistrytrials@corevitas.com",{"lat":102,"lon":103},42.37649,-71.23561,[],[],[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[18],[],{"nct_id":4,"found":79,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational registry study, meaning researchers will collect information about your health and treatments without giving you a specific intervention. Approximately 1500 participants will be included.","completed","CorEvitas International Adolescent Atopic Dermatitis Drug Safety and Effectiveness Registry","This is an observational study for adolescents with moderate to severe atopic dermatitis (eczema). It's called a registry, which means researchers will collect information about your condition and the treatments you receive over time. The goal is to better understand how atopic dermatitis affects young people and how well different treatments work and if they have any side effects. You can join if you are between 10 and 15 years old and have been diagnosed with moderate to severe atopic dermatitis by a skin doctor. This study is currently recruiting about 1500 participants across North America and some European countries.","Participants will be followed until they turn 18 years old.",100,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]