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.
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. This 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.
Study Type
OBSERVATIONAL
Enrollment
1,500
CorEvitas, LLC
Waltham, Massachusetts, United States
RECRUITINGAA 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.
Time frame: Through Study completion until the subject is 18 years
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
Time frame: at registry enrollment
Patient reported : Hair Concealment Question
Helps to determine alopecia
Time frame: every 6 months until the subject is 18 years
Patient reported : Stressful Life Event
Determines correlation between the disease \& stressful life events
Time frame: every 6 months until the subject is 18 years
Patient reported : Scalp Hair Assessment
Determines hair loss
Time frame: 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
Time frame: every 6 months until the subject is 18 years
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Patient reported : Numerical Rating Scale for Nasal irritation
Determines nasal irritation due to alopecia
Time frame: 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
Time frame: every 6 months until the subject is 18 years
Patient reported : Patient Health Questionnaire (PHQ)
Determines depression in subjects with alopecia
Time frame: every 6 months until the subject is 18 years
Patient reported :PROMIS Pediatric Sleep Disturbance 4 a
Determines sleep disturbance in subjects with alopecia
Time frame: every 6 months until the subject is 18 years
Patient reported : PROMIS Pediatric Stigma 8a
Determines Stigma in subjects with alopecia
Time frame: every 6 months until the subject is 18 years
Patient reported : Grief Assessment
Determines level of grief in subjects with alopecia
Time frame: every 6 months until the subject is 18 years
Patient reported : Pubertal Tanner Staging
Determines pubertal progression
Time frame: every 6 months until the subject is 18 years
Physician reported : Pubertal Progression: Tanner Staging Assessment
Determines pubertal progression
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: every 6 months until the subject is 18 years