CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry
NCT Number: NCT06562270
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Alopecia Areata
Sponsor: CorEvitas
Sex: ALL
Age: CHILD
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-07
Completion Date: 2099-12-31
Locations: CorEvitas, LLC, Waltham, Massachusetts, 02451, United States

Summary:
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/regulations in the country where the participating registry site is located.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|Patient reported : Hair Concealment Question, Helps to determine alopecia, every 6 months until the subject is 18 years|Patient reported : Stressful Life Event, Determines correlation between the disease \& stressful life events, every 6 months until the subject is 18 years|Patient reported : Scalp Hair Assessment, Determines hair loss, every 6 months until the subject is 18 years|Patient reported :Measures for Eye Irritation & Nail Appearance, Determines eye irritation \& nail appearance due to alopecia, every 6 months until the subject is 18 years|Patient reported : Numerical Rating Scale for Nasal irritation, Determines nasal irritation due to alopecia, every 6 months until the subject is 18 years|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, every 6 months until the subject is 18 years|Patient reported : Patient Health Questionnaire (PHQ), Determines depression in subjects with alopecia, every 6 months until the subject is 18 years|Patient reported :PROMIS Pediatric Sleep Disturbance 4 a, Determines sleep disturbance in subjects with alopecia, every 6 months until the subject is 18 years|Patient reported : PROMIS Pediatric Stigma 8a, Determines Stigma in subjects with alopecia, every 6 months until the subject is 18 years|Patient reported : Grief Assessment, Determines level of grief in subjects with alopecia, every 6 months until the subject is 18 years|Patient reported : Pubertal Tanner Staging, Determines pubertal progression, every 6 months until the subject is 18 years|Physician reported : Pubertal Progression: Tanner Staging Assessment, Determines pubertal progression, Every six Months until a subject is 18 years or the subjects reaches stage 5 of the tanner stangings assessment|Physician reported : Severity of Alopecia Tool (SALT), Determines percentage for hair loss \& ranges from 0 to 100, every 6 months until the subject is 18 years|Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA), Helps in clinical evaluation of Alopecia Aareata, every 6 months until the subject is 18 years|Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance, Determines hair loss in patients with alopecia aareata, every 6 months until the subject is 18 years