Atopic DermatitisNCT06238765
CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
An observational study of Atopic Dermatitis, run by CorEvitas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2023to 31 Dec 2099
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- To be eligible to participate in this registry, an individual must meet all the following criteria:
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in the registry:
- 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 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
Cathy Cheney, 508-555-1212, corevitasregistrytrials@corevitas.com
About this study
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.
Read the detailed description
The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
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 until the subject is 18 years
Secondary outcomes (17)
Percentage of patients with history of comorbidities
Measured: Time Frame: 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 until the subject is 18 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 until the subject is 18 years
Atopic dermatitis body surface area (BSA)
Measured: every 6 months until the subject is 18 years
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 until the subject is 18 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 until the subject is 18 years
Patient reported : Patient global assessments of disease control and severity
This determines the progression \& severity of the disease
Measured: every 6 months until the subject is 18 years
Physician reported : Pubertal Progression: Tanner Staging Assessment
Measured: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment
Patient reported: Patient Oriented Eczema Measure (POEM)
Measured: every 6 months until the subject is 18 years
Patient reported: Peak pruritus (itch) NRS
Measured: every 6 months until the subject is 18 years
Patient reported: Skin pain NRS
Measured: every 6 months until the subject is 18 years
Patient reported: Fatigue NRS
Measured: every 6 months until the subject is 18 years
Patient reported: Children's Dermatology Life Quality Index (CDLQI)
Measured: every 6 months until the subject is 18 years
Patient reported: Patient Health Questionnaire (PHQ-4)
Measured: every 6 months until the subject is 18 years
Patient reported: Atopic dermatitis control tool (ADCT)
Measured: every 6 months until the subject is 18 years
Patient reported: Asthma Control test
Measured: every 6 months until the subject is 18 years
Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
Measured: 6 months until the subject is 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start2 Dec 2023
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238765
- Sponsor's protocol ID
- CorEvitas-AD-555
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
- ClinicalTrials.gov ID
- NCT06238765
- Acronym / sponsor ID
- CorEvitas-AD-555
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 2 Feb 2024 (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.
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.
Detailed description
The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (4 listed)
- To be eligible to participate in this registry, an individual must meet all the following criteria:
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in the registry:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AD epidemiology, presentation, natural history, management, and outcomes
Time frame: Through Study completion until the subject is 18 years
The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.
17 secondary outcomes
Percentage of patients with history of comorbidities
Time frame: Time Frame: at registry enrollment
Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD
Time frame: every 6 months until the subject is 18 years
Physician reported: Nail changes due to atopic dermatitis (graduated VAS)
Time frame: every 6 months until the subject is 18 years
Atopic dermatitis body surface area (BSA)
Time frame: every 6 months until the subject is 18 years
Eczema Area and Severity Index (EASI) (calculated)
Time frame: every 6 months until the subject is 18 years
Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)
Time frame: every 6 months until the subject is 18 years
Patient reported : Patient global assessments of disease control and severity
Time frame: every 6 months until the subject is 18 years
Physician reported : Pubertal Progression: Tanner Staging Assessment
Time frame: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment
Patient reported: Patient Oriented Eczema Measure (POEM)
Time frame: every 6 months until the subject is 18 years
Patient reported: Peak pruritus (itch) NRS
Time frame: every 6 months until the subject is 18 years
Patient reported: Skin pain NRS
Time frame: every 6 months until the subject is 18 years
Patient reported: Fatigue NRS
Time frame: every 6 months until the subject is 18 years
Patient reported: Children's Dermatology Life Quality Index (CDLQI)
Time frame: every 6 months until the subject is 18 years
Patient reported: Patient Health Questionnaire (PHQ-4)
Time frame: every 6 months until the subject is 18 years
Patient reported: Atopic dermatitis control tool (ADCT)
Time frame: every 6 months until the subject is 18 years
Patient reported: Asthma Control test
Time frame: every 6 months until the subject is 18 years
Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)
Time frame: 6 months until the subject is 18 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 29 Jun 2026.
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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 4 inclusion and 3 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 29 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 until the subject is 18 years). 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 29 Jun 2026.