CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: CorEvitas

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • CorEvitas, LLC
      • Contact: Cathy Cheney; Phone Number: 508-555-1212; Email: corevitasregistrytrials@corevitas.com
      • Contact: Phone Number: 508-555-1212; Email: corevitasregistrytrials@corevitas.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 dermatology 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.
4. Has been prescribed a new commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents in the context of routine clinical care that is consistent with local prescribing guidelines and/or regulations for the country where the site is located.

A new therapy is a medication that the subject has never taken before.

1. At the time of registry enrollment OR
2. Within 6 months prior to registry enrollment In the opinion of the treating provider, is deemed a candidate for treatment with a commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents but has not received nor is planning to initiate treatment at the time of registry enrollment.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CorEvitas

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: CorEvitas-AA-565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No