CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
ConditionAlopecia Areata
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorEvitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients are enrolled in the AA Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Alopecia Areata
Trial outcomes
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.
Time frame
A minimum of 10 years from last patient enrolledSecondary outcomes
1
Physician Reported - Skindex-16
Time frame
every 6 months for 10 years2
Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)
Time frame
every 6 months for 10 years3
Physician Reported - Dermatology Life Quality Index (DLQI)
Time frame
every 6 months for 10 years4
Physician Reported - Severity of Alopecia Tool (SALT)
Time frame
every 6 months for 10 years Source ClinicalTrials.gov