Alopecia Areata
Conditions
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Inclusion criteria
To be eligible to participate in this registry, an individual must meet all the following criteria: 1. Has ever been diagnosed with severe AA by a dermatologist or a qualified healthcare provider. 2. Is 12-17 years of age at the time of enrollment. 3. Is willing to provide consent/assent for participation in the registry.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in the registry: 1. Is participating or planning to participate in a blinded clinical trial for any investigational medication. 2. Is unwilling or unable to provide standing height measurements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AA epidemiology, presentation, natural history, management, and outcomes | Through Study completion until the subject is 18 years | The major clinical outcomes include an assessment of the epidemiology of Alopecia Areata; to better understand the presentation, natural history, management and outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with history of comorbidities | at registry enrollment | 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 |
| Patient reported : Hair Concealment Question | every 6 months until the subject is 18 years | Helps to determine alopecia |
| Patient reported : Stressful Life Event | every 6 months until the subject is 18 years | Determines correlation between the disease \& stressful life events |
| Patient reported : Scalp Hair Assessment | every 6 months until the subject is 18 years | Determines hair loss |
| Patient reported :Measures for Eye Irritation & Nail Appearance | every 6 months until the subject is 18 years | Determines eye irritation \& nail appearance due to alopecia |
| Patient reported : Numerical Rating Scale for Nasal irritation | every 6 months until the subject is 18 years | Determines nasal irritation due to alopecia |
| Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO) | every 6 months until the subject is 18 years | 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 |
| Patient reported : Patient Health Questionnaire (PHQ) | every 6 months until the subject is 18 years | Determines depression in subjects with alopecia |
| Patient reported :PROMIS Pediatric Sleep Disturbance 4 a | every 6 months until the subject is 18 years | Determines sleep disturbance in subjects with alopecia |
| Patient reported : PROMIS Pediatric Stigma 8a | every 6 months until the subject is 18 years | Determines Stigma in subjects with alopecia |
| Patient reported : Grief Assessment | every 6 months until the subject is 18 years | Determines level of grief in subjects with alopecia |
| Patient reported : Pubertal Tanner Staging | every 6 months until the subject is 18 years | Determines pubertal progression |
| 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 | Determines pubertal progression |
| Physician reported : Severity of Alopecia Tool (SALT) | every 6 months until the subject is 18 years | Determines percentage for hair loss \& ranges from 0 to 100 |
| Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA) | every 6 months until the subject is 18 years | Helps in clinical evaluation of Alopecia Aareata |
| Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance | every 6 months until the subject is 18 years | Determines hair loss in patients with alopecia aareata |
Countries
United States
Contacts
CONTACTCorEvitas
Outcome results
None listed