CorEvitas Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorEvitas
About this trial
This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for patients with atopic dermatitis under the care of a licensed dermatologist or qualified physician extender. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.
Condition or disease :
Atopic Dermatitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At the time of registry enrollment OR
Within 12 months prior to registry enrollment
Disqualifiers
None
Trial population
Patients are enrolled in the Atopic Dermatitis Registry during regularly scheduled office visits clinical encounters. Selected dermatologists are invited to participate as investigators in the Registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Non-Interventional Registry
Other interventionObservational Non-Interventional Registry
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Atopic Dermatitis1 intervention
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, an average of 10yearsSecondary outcomes
1
Percentage of patients with history of comorbidities
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 for 10 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 for 10 years4
Physician reported: Atopic dermatitis body surface area (BSA)
Time frame
every 6 months for 10 years Source ClinicalTrials.gov