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NCT Number: NCT06238765

CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

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.

Recruiting

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location status: Recruiting

Location contact

Cathy Cheney

CONTACT

[email protected]

508-555-1212

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of patients with history of comorbidities

    Time frame: Time Frame: at registry enrollment

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

    Time frame: every 6 months until the subject is 18 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 until the subject is 18 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. Atopic dermatitis body surface area (BSA)

    Time frame: every 6 months until the subject is 18 years

  5. Eczema Area and Severity Index (EASI) (calculated)

    Time frame: every 6 months until the subject is 18 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 until the subject is 18 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 until the subject is 18 years

    This determines the progression & severity of the disease

  8. 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

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

    Time frame: every 6 months until the subject is 18 years

  10. Patient reported: Peak pruritus (itch) NRS

    Time frame: every 6 months until the subject is 18 years

  11. Patient reported: Skin pain NRS

    Time frame: every 6 months until the subject is 18 years

  12. Patient reported: Fatigue NRS

    Time frame: every 6 months until the subject is 18 years

  13. Patient reported: Children's Dermatology Life Quality Index (CDLQI)

    Time frame: every 6 months until the subject is 18 years

  14. Patient reported: Patient Health Questionnaire (PHQ-4)

    Time frame: every 6 months until the subject is 18 years

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

    Time frame: every 6 months until the subject is 18 years

  16. Patient reported: Asthma Control test

    Time frame: every 6 months until the subject is 18 years

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

    Time frame: 6 months until the subject is 18 years

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2023
Primary completion
2099
Study completion
2099
First posted
Feb 2, 2024
Registry last updated
Jun 29, 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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