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Enrolling by Invitation

NCT Number: NCT04504955

CorEvitas Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness

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

Enrolling by Invitation

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Key information

About this study

The objective of the CorEvitas Atopic Dermatitis (AD) Registry is to create a national cohort of patients with atopic dermatitis. Data collected will be used to extensively evaluate the effectiveness and safety of medications used to treat atopic dermatitis. This will be done through the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Has been diagnosed with AD by a dermatologist or qualified dermatology provider.

  • Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
  • Willing and able to provide consent for participation in the registry. 4) Willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip/postal code, and email address OR phone number at a minimum) if required based on registry location and applicable laws and regulations. 5) Has been prescribed a new Enrollment Eligible Medication. A new therapy is a medication that the subject has never taken before.
  • At the time of registry enrollment OR
  • Within 12 months prior to registry enrollment

Exclusion criteria

1)Is participating or planning to participate in a blinded clinical trial for an AD drug.

Follow-Up Criteria

Registry Follow-Up data collection should be done at the time of routine clinical encounters approximately every 6 months. Routine or standard of care clinical encounters may occur in between two registry visits, but the data collected in the Follow-Up forms should cover the time period since the last registry visit.

For planning purposes, each Follow-Up visit is anchored to the date of the last eligible registry visit. A Follow-Up visit is eligible for payment if 150 days have passed since the last visit submission. A Follow-Up visit is not eligible for payment if conducted less than 150 days since the last registry visits except when the EARLY Follow-Up visit Criteria are satisfied.

EARLY Follow-Up Criteria

A registry Follow-Up visit should be conducted whenever a patient is prescribed or receiving the first dose of a new Eligible Medication even if less than 150 days have passed since the last registry visit. When the EARLY Follow-Up criteria are met, the next anticipated registry visit is calculated from the date of the Early Follow-Up visit.

Treatment and study plan

Observational Non-Interventional Registry

Other

Observational Non-Interventional Registry

Primary outcomes

  1. AD epidemiology, presentation, natural history, management, and outcomes

    Time frame: Through Study completion, an average of 10years

    The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.

Secondary outcomes

  1. Percentage of patients with history of comorbidities

    Time frame: at registry enrollment

  2. Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)

    Time frame: every 6 months for 10 years

    Score: 0-4, with high score indicating widespread of atopic dermatitis

  3. Physician reported: Nail changes due to atopic dermatitis (graduated VAS)

    Time frame: every 6 months for 10 years

    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

  4. Physician reported: Atopic dermatitis body surface area (BSA)

    Time frame: every 6 months for 10 years

  5. Physician reported: Eczema Area and Severity Index (EASI) (calculated)

    Time frame: every 6 months for 10 years

    The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.

  6. Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)

    Time frame: every 6 months for 10 years

    The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe. For the Overall Score [SCORAD], select a lesion that that is representative of the body and score using the same severity scale

  7. Patient reported: Patient global assessments of disease control and severity

    Time frame: every 6 months for 10 years

    This determines the progression & severity of the disease

  8. Patient reported: Patient Oriented Eczema Measure (POEM)

    Time frame: every 6 months for 10 years

  9. Patient reported: Peak pruritus (itch) NRS

    Time frame: every 6 months for 10 years

  10. Patient reported: Skin pain NRS

    Time frame: every 6 months for 10 years

  11. Patient reported: Fatigue NRS

    Time frame: every 6 months for 10 years

  12. Patient reported: Dermatology Life Quality Index (DLQI)

    Time frame: every 6 months for 10 years

  13. Patient reported: Work Productivity and Activity Impairment (WPAI)

    Time frame: every 6 months for 10 years

  14. Patient reported: Atopic dermatitis control tool (ADCT)

    Time frame: every 6 months for 10 years

  15. Patient reported: Itch triggers (PROMIS)

    Time frame: every 6 months for 10 years

  16. Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)

    Time frame: 6 months for 10 years

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2020
Primary completion
2100
Study completion
2100
First posted
Aug 7, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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