NCT05745389

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
897mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Oct 2022Dec 2099

Study Start

First participant enrolled

October 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
76.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2099

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

77.2 years

First QC Date

February 16, 2023

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alopecia epidemiology, presentation, natural history, management, and outcomes

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

    A minimum of 10 years from last patient enrolled

Secondary Outcomes (10)

  • Physician Reported - Skindex-16

    every 6 months for 10 years

  • Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)

    every 6 months for 10 years

  • Physician Reported - Dermatology Life Quality Index (DLQI)

    every 6 months for 10 years

  • Physician Reported - Severity of Alopecia Tool (SALT)

    every 6 months for 10 years

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

    every 6 months for 10 years

  • +5 more secondary outcomes

Study Arms (1)

Alopecia Areata

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are enrolled in the AA Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

October 25, 2022

Primary Completion (Estimated)

December 31, 2099

Study Completion (Estimated)

December 31, 2099

Last Updated

February 9, 2026

Record last verified: 2026-01

Locations