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

NCT06562270 | Recruiting

• 1 other identifier: CorEvitas-AA-565
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Percentage of patients with history of comorbidities

  at registry enrollment

• Patient reported : Hair Concealment Question

  every 6 months until the subject is 18 years

• Patient reported : Stressful Life Event

  every 6 months until the subject is 18 years

• Patient reported : Scalp Hair Assessment

  every 6 months until the subject is 18 years

• Patient reported :Measures for Eye Irritation & Nail Appearance

  every 6 months until the subject is 18 years

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

CorEvitas

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 20, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

US (1)