Alopecia AreataNCT05745389
CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
An observational study of Alopecia Areata, run by CorEvitas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 31 Dec 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CorEvitas, LLC
Waltham, Massachusetts, 02451
Jeffrey Greenberg, corevitasregistrytrials@corevitas.com
About this study
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.
Read the detailed description
The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
- Conditions
- Alopecia Areata
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alopecia Areata | Pts presenting to enrolling sites across the US are invited to enroll if eligible |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A minimum of 10 years from last patient enrolled
Secondary outcomes (10)
Physician Reported - Skindex-16
Measured: every 6 months for 10 years
Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)
Measured: every 6 months for 10 years
Physician Reported - Dermatology Life Quality Index (DLQI)
Measured: every 6 months for 10 years
Physician Reported - Severity of Alopecia Tool (SALT)
Measured: every 6 months for 10 years
Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA)
Measured: every 6 months for 10 years
Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance
Measured: every 6 months for 10 years
Physician Reported - Alopecia Areata Scale (AAS)
Measured: every 6 months for 10 years
Patient Reported - Scalp Hair Assessment PRO
Measured: every 6 months for 10 years
Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance
Measured: every 6 months for 10 years
Patient Reported - Work Productivity and Activity Impairment (WPAI)
Measured: every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start25 Oct 2022
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745389
- Sponsor's protocol ID
- CorEvitas-AA-560
- Status last verified
- Jan 2026
- First submitted
- 16 Feb 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
- ClinicalTrials.gov ID
- NCT05745389
- Acronym / sponsor ID
- CorEvitas-AA-560
- Conditions
- Alopecia Areata
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alopecia Areata | – | –Pts presenting to enrolling sites across the US are invited to enroll if eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- A subject must meet all the following criteria to participate in the registry:
Key exclusion criteria (3 listed)
- Any of the following would exclude the subject from participating in the registry:
- Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alopecia epidemiology, presentation, natural history, management, and outcomes
Time frame: A minimum of 10 years from last patient enrolled
The major clinical outcomes include an assessment of the epidemiology of AA; to better understand the presentation, natural history, management and outcomes.
10 secondary outcomes
Physician Reported - Skindex-16
Time frame: every 6 months for 10 years
Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: every 6 months for 10 years
Physician Reported - Dermatology Life Quality Index (DLQI)
Time frame: every 6 months for 10 years
Physician Reported - Severity of Alopecia Tool (SALT)
Time frame: every 6 months for 10 years
Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA)
Time frame: every 6 months for 10 years
Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance
Time frame: every 6 months for 10 years
Physician Reported - Alopecia Areata Scale (AAS)
Time frame: every 6 months for 10 years
Patient Reported - Scalp Hair Assessment PRO
Time frame: every 6 months for 10 years
Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance
Time frame: every 6 months for 10 years
Patient Reported - Work Productivity and Activity Impairment (WPAI)
Time frame: every 6 months for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Cheney ((508) 408-5435, corevitasregistrytrials@corevitas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alopecia epidemiology, presentation, natural history, management, and outcomes (time frame: A minimum of 10 years from last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.