Registry for safety and effectiveness of alopecia areata treatments

CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry

This study is trying to collect information from about 5,000 people with alopecia areata to see how safe and effective different treatments are over time.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CorEvitas (Research network)
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT05745389 on ClinicalTrials.gov

What this trial studies

This observational cohort registry aims to recruit approximately 5,000 subjects diagnosed with alopecia areata under dermatological care across 100 clinical sites in North America. The primary objective is to gather long-term data on the safety and effectiveness of various treatments for alopecia areata, addressing the limited understanding of these factors post-regulatory approval. By collecting structured data, including patient-reported and clinician-reported outcomes, the registry will help characterize the disease's natural history and inform clinical decision-making. Additionally, it will allow for linkages to other databases for comprehensive evaluation of treatment impacts.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who have been diagnosed with alopecia areata by a qualified dermatologist and are starting a prescribed treatment.

Not a fit: Patients currently participating in a double-blind randomized trial for an alopecia areata drug will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of alopecia areata treatments, ultimately improving patient care.

How similar studies have performed: Other observational studies have successfully gathered long-term data on treatment safety and effectiveness, making this approach both relevant and valuable.

Eligibility criteria

Inclusion Criteria:

* A subject must meet all the following criteria to participate in the registry:

  1. Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
  2. Is at least 18 years of age or older.
  3. Is willing to provide Personal Information.
  4. 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:

  1. 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.

Where this trial is running

Waltham, Massachusetts

• CorEvitas, LLC — Waltham, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Cathy Cheney

Conditions Alopecia Areata