Registry for adolescents with severe alopecia areata

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

This study is tracking adolescents with severe alopecia areata to see how well their treatments work and to understand their condition better over time.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: CorEvitas (Research network)
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT06562270 on ClinicalTrials.gov

What this trial studies

This observational registry focuses on adolescents aged 12-17 diagnosed with severe alopecia areata who are receiving routine care from dermatology providers. The study aims to evaluate the long-term safety and effectiveness of treatments for severe alopecia areata through standardized data collection, including patient-reported and clinician-reported outcomes. Data gathered will help characterize the disease's natural history, assess medication effectiveness and safety, and inform clinical decision-making. The registry will also track comorbidities, adverse events, and medication utilization.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-17 who have been diagnosed with severe alopecia areata and are willing to participate in the registry.

Not a fit: Patients who do not have a diagnosis of severe alopecia areata or are outside the age range of 12-17 may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of treatments for adolescents with severe alopecia areata, leading to improved care strategies.

How similar studies have performed: While this registry approach is not novel, similar studies have successfully provided real-world evidence for various conditions, indicating potential for valuable insights in this context.

Eligibility criteria

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.

Where this trial is running

Waltham, Massachusetts

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

Study contacts

• Study coordinator: CorEvitas

Conditions Alopecia Areata