Status:

RECRUITING

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

Lead Sponsor:

CorEvitas

Conditions:

Alopecia Areata

Eligibility:

All Genders

12-17 years

Brief Summary

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 determ...

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 coll...

Eligibility Criteria

Inclusion

  • To be eligible to participate in this registry, an individual must meet all the following criteria:
  • Has ever been diagnosed with severe AA by a dermatologist or a qualified dermatology provider.
  • Is 12-17 years of age at the time of enrollment.
  • Is willing to provide consent/assent for participation in the registry.
  • 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.
  • At the time of registry enrollment OR
  • 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

  • An individual who meets any of the following criteria will be excluded from participation in the registry:
  • Is participating or planning to participate in a blinded clinical trial for any investigational medication.
  • Is unwilling or unable to provide standing height measurements.

Key Trial Info

Start Date :

March 7 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2099

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT06562270

Start Date

March 7 2024

End Date

December 31 2099

Last Update

January 9 2025

Active Locations (1)

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1

CorEvitas, LLC

Waltham, Massachusetts, United States, 02451