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NCT Number: NCT05745389

CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry

Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location status: Recruiting

Location contact

Jeffrey Greenberg

CONTACT

[email protected]

About this study

The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A subject must meet all the following criteria to participate in the registry:
  • Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
  • Is at least 18 years of age or older.
  • Is willing to provide Personal Information.
  • Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.

Exclusion criteria

  • Any of the following would exclude the subject from participating in the registry:
  • Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:

Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

Treatment and study plan

Primary outcomes

  1. Alopecia epidemiology, presentation, natural history, management, and outcomes

    Time frame: A minimum of 10 years from last patient enrolled

    The major clinical outcomes include an assessment of the epidemiology of AA; to better understand the presentation, natural history, management and outcomes.

Secondary outcomes

  1. Physician Reported - Skindex-16

    Time frame: every 6 months for 10 years

  2. Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)

    Time frame: every 6 months for 10 years

  3. Physician Reported - Dermatology Life Quality Index (DLQI)

    Time frame: every 6 months for 10 years

  4. Physician Reported - Severity of Alopecia Tool (SALT)

    Time frame: every 6 months for 10 years

  5. Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA)

    Time frame: every 6 months for 10 years

  6. Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance

    Time frame: every 6 months for 10 years

  7. Physician Reported - Alopecia Areata Scale (AAS)

    Time frame: every 6 months for 10 years

  8. Patient Reported - Scalp Hair Assessment PRO

    Time frame: every 6 months for 10 years

  9. Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance

    Time frame: every 6 months for 10 years

  10. Patient Reported - Work Productivity and Activity Impairment (WPAI)

    Time frame: every 6 months for 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Cathy Cheney

CONTACT

[email protected]

(508) 408-5435

Resham Sanzagiri

CONTACT

[email protected]

508-948-0898

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2022
Primary completion
2099
Study completion
2099
First posted
Feb 27, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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