Atopic DermatitisNCT04504955
CorEvitas Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
An observational study of Atopic Dermatitis, run by CorEvitas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Observational Non-Interventional Registry
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to Dec 2100
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CorEvitas, LLC
Waltham, Massachusetts, 02451
Atopic Dermatitis Registry Team, 508-408-5531, ppd_coreatopicderm@thermofisher.com
About this study
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Observational Non-Interventional Registry
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Non-Interventional RegistryOther
Observational Non-Interventional Registry
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | Pts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible Receives: Other: Observational Non-Interventional Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Study completion, an average of 10years
Secondary outcomes (16)
Percentage of patients with history of comorbidities
Measured: at registry enrollment
Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Score: 0-4, with high score indicating widespread of atopic dermatitis
Measured: every 6 months for 10 years
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
Measured: every 6 months for 10 years
Physician reported: Atopic dermatitis body surface area (BSA)
Measured: every 6 months for 10 years
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.
Measured: every 6 months for 10 years
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
Measured: every 6 months for 10 years
Patient reported: Patient global assessments of disease control and severity
This determines the progression \& severity of the disease
Measured: every 6 months for 10 years
Patient reported: Patient Oriented Eczema Measure (POEM)
Measured: every 6 months for 10 years
Patient reported: Peak pruritus (itch) NRS
Measured: every 6 months for 10 years
Patient reported: Skin pain NRS
Measured: every 6 months for 10 years
Patient reported: Fatigue NRS
Measured: every 6 months for 10 years
Patient reported: Dermatology Life Quality Index (DLQI)
Measured: every 6 months for 10 years
Patient reported: Work Productivity and Activity Impairment (WPAI)
Measured: every 6 months for 10 years
Patient reported: Atopic dermatitis control tool (ADCT)
Measured: every 6 months for 10 years
Patient reported: Itch triggers (PROMIS)
Measured: every 6 months for 10 years
Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
Measured: 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start14 Jul 2020
- Primary completionDec 2100 (estimated)
- Study completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504955
- Sponsor's protocol ID
- CorEvitas-AD-550
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT04504955
- Acronym / sponsor ID
- CorEvitas-AD-550
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | Other: Observational Non-Interventional RegistryPts presenting to enrolling sites across in North America and select European countries are invited to enroll if eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Non-Interventional RegistryObservational Non-Interventional Registry | Other | Atopic Dermatitis |
Primary outcome
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.
16 secondary outcomes
Percentage of patients with history of comorbidities
Time frame: at registry enrollment
Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Time frame: every 6 months for 10 years
Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
Time frame: every 6 months for 10 years
Physician reported: Atopic dermatitis body surface area (BSA)
Time frame: every 6 months for 10 years
Physician reported: Eczema Area and Severity Index (EASI) (calculated)
Time frame: every 6 months for 10 years
Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)
Time frame: every 6 months for 10 years
Patient reported: Patient global assessments of disease control and severity
Time frame: every 6 months for 10 years
Patient reported: Patient Oriented Eczema Measure (POEM)
Time frame: every 6 months for 10 years
Patient reported: Peak pruritus (itch) NRS
Time frame: every 6 months for 10 years
Patient reported: Skin pain NRS
Time frame: every 6 months for 10 years
Patient reported: Fatigue NRS
Time frame: every 6 months for 10 years
Patient reported: Dermatology Life Quality Index (DLQI)
Time frame: every 6 months for 10 years
Patient reported: Work Productivity and Activity Impairment (WPAI)
Time frame: every 6 months for 10 years
Patient reported: Atopic dermatitis control tool (ADCT)
Time frame: every 6 months for 10 years
Patient reported: Itch triggers (PROMIS)
Time frame: every 6 months for 10 years
Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
Time frame: 6 months for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atopic Dermatitis Registry Team (508-408-5531, ppd_coreatopicderm@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AD epidemiology, presentation, natural history, management, and outcomes (time frame: Through Study completion, an average of 10years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.