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RecruitingNCT04504955Updated Aug 26, 2026

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

An observational study in Atopic Dermatitis, sponsored by CorEvitas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by CorEvitas · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Atopic Dermatitis

Browse trials for

03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

CorEvitas is the lead sponsor of 28 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Eligibility criteria

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

2) 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.

3) 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.

  1. At the time of registry enrollment OR
  2. 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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Atopic Dermatitis

    Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible

    Other: Observational Non-Interventional Registry

Interventions

  • OtherObservational Non-Interventional Registry

    Observational Non-Interventional Registry

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What researchers measure

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 10years

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)

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

    Time frame: every 6 months for 10 years

  3. 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 years

  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)

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

    Time frame: every 6 months for 10 years

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

    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

    Time frame: every 6 months for 10 years

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

    This determines the progression \& severity of the disease

    Time frame: every 6 months for 10 years

  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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Dec 2100, 965 months after the start.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 965 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2020
First posted
Aug 7, 2020
StartActual
Jul 14, 2020
Primary completionEst.
Dec 2100
CompletionEst.
Dec 2100
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04504955
Lead sponsor
CorEvitas
Responsible party
Sponsor
First posted
Aug 7, 2020
Start date
Jul 14, 2020
Primary completion
Dec 2100 (estimated)
Completion
Dec 2100 (estimated)
Last update
Aug 26, 2026

Study contacts

Atopic Dermatitis Registry Team
Contact
ppd_coreatopicderm@thermofisher.com
508-408-5531

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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