Alopecia AreataNCT06562270
CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry
An observational study of Alopecia Areata, run by CorEvitas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Alopecia Areata
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 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 12 to 17 years
- All sexes
- Child
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.
Who may be able to join
- 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 healthcare provider.
- Is 12-17 years of age at the time of enrollment.
- Is willing to provide consent/assent for participation in the registry.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CorEvitas contact
United States1 site, 1 recruiting
- Recruiting
CorEvitas, LLC
Waltham, Massachusetts, 02451
Cathy Cheney, 508-555-1212, corevitasregistrytrials@corevitas.com
508-555-1212, corevitasregistrytrials@corevitas.com
About this study
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.
Read the 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 collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers.
This will be enabled through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
- Conditions
- Alopecia Areata
- Medical subject headings
- Alopecia Areata
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Study completion until the subject is 18 years
Secondary outcomes (16)
Percentage of patients with history of comorbidities
Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs
Measured: at registry enrollment
Patient reported : Hair Concealment Question
Helps to determine alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : Stressful Life Event
Determines correlation between the disease \& stressful life events
Measured: every 6 months until the subject is 18 years
Patient reported : Scalp Hair Assessment
Determines hair loss
Measured: every 6 months until the subject is 18 years
Patient reported :Measures for Eye Irritation & Nail Appearance
Determines eye irritation \& nail appearance due to alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : Numerical Rating Scale for Nasal irritation
Determines nasal irritation due to alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO)
To assess the consequences associated with Alopecia Areata (AA) of the highest priority to the patients, including hair loss signs, emotional symptoms, and activity limitations
Measured: every 6 months until the subject is 18 years
Patient reported : Patient Health Questionnaire (PHQ)
Determines depression in subjects with alopecia
Measured: every 6 months until the subject is 18 years
Patient reported :PROMIS Pediatric Sleep Disturbance 4 a
Determines sleep disturbance in subjects with alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : PROMIS Pediatric Stigma 8a
Determines Stigma in subjects with alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : Grief Assessment
Determines level of grief in subjects with alopecia
Measured: every 6 months until the subject is 18 years
Patient reported : Pubertal Tanner Staging
Determines pubertal progression
Measured: every 6 months until the subject is 18 years
Physician reported : Pubertal Progression: Tanner Staging Assessment
Determines pubertal progression
Measured: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the tanner stangings assessment
Physician reported : Severity of Alopecia Tool (SALT)
Determines percentage for hair loss \& ranges from 0 to 100
Measured: every 6 months until the subject is 18 years
Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA)
Helps in clinical evaluation of Alopecia Aareata
Measured: every 6 months until the subject is 18 years
Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance
Determines hair loss in patients with alopecia aareata
Measured: every 6 months until the subject is 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start7 Mar 2024
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562270
- Sponsor's protocol ID
- CorEvitas-AA-565
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2024
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry
- ClinicalTrials.gov ID
- NCT06562270
- Acronym / sponsor ID
- CorEvitas-AA-565
- Conditions
- Alopecia Areata
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 20 Aug 2024 (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 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.
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 collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers.
This will be enabled through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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 healthcare provider.
- Is 12-17 years of age at the time of enrollment.
- Is willing to provide consent/assent for participation in the registry.
Key exclusion criteria (3 listed)
- 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.
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
AA epidemiology, presentation, natural history, management, and outcomes
Time frame: Through Study completion until the subject is 18 years
The major clinical outcomes include an assessment of the epidemiology of Alopecia Areata; to better understand the presentation, natural history, management and outcomes.
16 secondary outcomes
Percentage of patients with history of comorbidities
Time frame: at registry enrollment
Patient reported : Hair Concealment Question
Time frame: every 6 months until the subject is 18 years
Patient reported : Stressful Life Event
Time frame: every 6 months until the subject is 18 years
Patient reported : Scalp Hair Assessment
Time frame: every 6 months until the subject is 18 years
Patient reported :Measures for Eye Irritation & Nail Appearance
Time frame: every 6 months until the subject is 18 years
Patient reported : Numerical Rating Scale for Nasal irritation
Time frame: every 6 months until the subject is 18 years
Patient reported : Alopecia Areata Patient Priority Outcomes (AAPPO)
Time frame: every 6 months until the subject is 18 years
Patient reported : Patient Health Questionnaire (PHQ)
Time frame: every 6 months until the subject is 18 years
Patient reported :PROMIS Pediatric Sleep Disturbance 4 a
Time frame: every 6 months until the subject is 18 years
Patient reported : PROMIS Pediatric Stigma 8a
Time frame: every 6 months until the subject is 18 years
Patient reported : Grief Assessment
Time frame: every 6 months until the subject is 18 years
Patient reported : Pubertal Tanner Staging
Time frame: every 6 months until the subject is 18 years
Physician reported : Pubertal Progression: Tanner Staging Assessment
Time frame: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the tanner stangings assessment
Physician reported : Severity of Alopecia Tool (SALT)
Time frame: every 6 months until the subject is 18 years
Physician reported : Alopecia Areata Investigator Global Assessment Scale (AA-IGA)
Time frame: every 6 months until the subject is 18 years
Physician reported : Measures for Eyebrow & Eyelash Hair loss and Nail Appearance
Time frame: every 6 months until the subject is 18 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 17 Aug 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.
CorEvitas contact
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 4 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 17 Aug 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 CorEvitas, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AA epidemiology, presentation, natural history, management, and outcomes (time frame: Through Study completion until the subject is 18 years). 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 17 Aug 2026.