CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry
ConditionAlopecia Areata
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorCorEvitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Through Study completion until the subject is 18 yearsSecondary outcomes
1
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
Time frame
at registry enrollment2
Patient reported : Hair Concealment Question
Helps to determine alopecia
Time frame
every 6 months until the subject is 18 years3
Patient reported : Stressful Life Event
Determines correlation between the disease \& stressful life events
Time frame
every 6 months until the subject is 18 years4
Patient reported : Scalp Hair Assessment
Determines hair loss
Time frame
every 6 months until the subject is 18 years Source ClinicalTrials.gov