[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06562270":3,"trial-entities:NCT06562270":114,"trial-summary:NCT06562270":118},{"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":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":21,"eligibility_criteria":86,"std_ages":90,"locations":92,"central_contacts":109,"overall_officials":111,"references":112,"see_also_links":113},"NCT06562270","CorEvitas-AA-565","CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry","RECRUITING","2099-12-31","2026-08","2026-08-17","2024-03-07","CorEvitas","NETWORK",false,"Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areata,receiving routine care from dermatology providers. Visit schedules for patients will be determined by the provider in accordance with routine clinical care, and any prescriptions provided to patients will adhere to product availability and local prescribing guidelines\u002Fregulations in the country where the participating registry site is located.","The objective of the registry is to create a cohort of adolescent subjects to evaluate the long-term real-world safety and effectiveness of routine clinical care of treatments for severe AA. Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers.\n\nThis will be enabled 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 data.",[18],"Alopecia Areata",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1500,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"AA epidemiology, presentation, natural history, management, and outcomes","The major clinical outcomes include an assessment of the epidemiology of Alopecia Areata; to better understand the presentation, natural history, management and outcomes.","Through Study completion until the subject is 18 years",[33,37,41,44,47,50,53,56,59,62,65,68,71,74,77,80],{"measure":34,"description":35,"timeFrame":36},"Percentage of patients with history of comorbidities","Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs","at registry enrollment",{"measure":38,"description":39,"timeFrame":40},"Patient reported : Hair Concealment Question","Helps to determine alopecia","every 6 months until the subject is 18 years",{"measure":42,"description":43,"timeFrame":40},"Patient reported : Stressful Life Event","Determines correlation between the disease \\& stressful life events",{"measure":45,"description":46,"timeFrame":40},"Patient reported : Scalp Hair Assessment","Determines hair loss",{"measure":48,"description":49,"timeFrame":40},"Patient reported :Measures for Eye Irritation & Nail Appearance","Determines eye irritation \\& nail appearance due to alopecia",{"measure":51,"description":52,"timeFrame":40},"Patient reported : Numerical Rating Scale for Nasal irritation","Determines nasal irritation due to alopecia",{"measure":54,"description":55,"timeFrame":40},"Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO)","To assess the consequences associated with Alopecia Areata (AA) of the highest priority to the patients, including hair loss signs, emotional symptoms, and activity limitations",{"measure":57,"description":58,"timeFrame":40},"Patient reported : Patient Health Questionnaire (PHQ)","Determines depression in subjects with alopecia",{"measure":60,"description":61,"timeFrame":40},"Patient reported :PROMIS Pediatric Sleep Disturbance 4 a","Determines sleep disturbance in subjects with alopecia",{"measure":63,"description":64,"timeFrame":40},"Patient reported : PROMIS Pediatric Stigma 8a","Determines Stigma in subjects with alopecia",{"measure":66,"description":67,"timeFrame":40},"Patient reported : Grief Assessment","Determines level of grief in subjects with alopecia",{"measure":69,"description":70,"timeFrame":40},"Patient reported : Pubertal Tanner Staging","Determines pubertal progression",{"measure":72,"description":70,"timeFrame":73},"Physician reported : Pubertal Progression: Tanner Staging Assessment","Every six Months until a subject is 18 years or the subjects reaches stage 5 of the tanner stangings assessment",{"measure":75,"description":76,"timeFrame":40},"Physician reported : Severity of Alopecia Tool (SALT)","Determines percentage for hair loss \\& ranges from 0 to 100",{"measure":78,"description":79,"timeFrame":40},"Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA)","Helps in clinical evaluation of Alopecia Aareata",{"measure":81,"description":82,"timeFrame":40},"Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance","Determines hair loss in patients with alopecia aareata","ALL","12 Years","17 Years",{"inclusion":87,"exclusion":88,"raw_text":89},[],[],"Inclusion Criteria:\n\nTo be eligible to participate in this registry, an individual must meet all the following criteria:\n\n1. Has ever been diagnosed with severe AA by a dermatologist or a qualified healthcare provider.\n2. Is 12-17 years of age at the time of enrollment.\n3. Is willing to provide consent\u002Fassent for participation in the registry.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the registry:\n\n1. Is participating or planning to participate in a blinded clinical trial for any investigational medication.\n2. Is unwilling or unable to provide standing height measurements.",[91],"CHILD",[93],{"facility":94,"status":7,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":106},"CorEvitas, LLC","Waltham","Massachusetts","02451","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"Cathy Cheney","CONTACT","508-555-1212","corevitasregistrytrials@corevitas.com",{"role":102,"phone":103,"email":104},{"lat":107,"lon":108},42.37649,-71.23561,[110],{"name":12,"role":102},[],[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Alopecia",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an observational registry that plans to enroll 1500 participants. It is not testing a specific drug, but rather observing routine care.","completed","CorEvitas International Adolescent Alopecia Areata Registry","This is an observational study (registry) for adolescents aged 12 to 17 who have been diagnosed with severe alopecia areata (AA), a condition where the immune system attacks hair follicles, causing hair loss. The registry will collect information on how AA affects adolescents, how it's managed with routine care from dermatology providers, and the long-term safety and effectiveness of different treatments. The goal is to better understand the disease, evaluate existing medications, and provide information to help doctors and patients make informed decisions about treatment. You would be part of a group of 1500 participants, and your information would be collected until you turn 18 years old.","You will be followed until you are 18 years old.",107,"Your visit schedule will be determined by your doctor as part of your routine clinical care. Data will be collected through patient-reported outcomes and clinician-reported outcomes.","Not stated in the trial record.",[],"v2"]