CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-15
SponsorCorEvitas
About this trial
Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider
Is 10 - 15 years of age at the time of enrollment.
Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment
Disqualifiers
Is participating or planning to participate in a blinded clinical trial for an AD drug.
Is unwilling or unable to provide standing height measurements.
Trial population
Subjects can enroll as early as age 10 and will be followed until the age of 18; therefore, the maximum duration a subject can be enrolled is \< 8 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
AD epidemiology, presentation, natural history, management, and outcomes
The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; 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
Time frame
Time Frame: at registry enrollment2
Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD
Score: 0-4, with high score indicating widespread of atopic dermatitis
Time frame
every 6 months until the subject is 18 years3
Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
Scale - 0 (Clear/Normal) to 100 (Severe Abnormalities). Lower numbers are for mild abnormalities in a few nails, higher numbers are for more severe changes in many nails
Time frame
every 6 months until the subject is 18 years4
Atopic dermatitis body surface area (BSA)
Time frame
every 6 months until the subject is 18 years Source ClinicalTrials.gov