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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all the following criteria:
A new therapy is a medication that the subject has never taken before.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the registry:
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Subjects can enroll as early as age 12 and will be followed until the age of 18; therefore, the maximum duration a subject can be enrolled is 6 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CorEvitas | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CorEvitas, LLC | Recruiting | Waltham | Massachusetts | 02451 | United States |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |