CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 10 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- AD epidemiology, presentation, natural history, management, and outcomes [Time frame: Through Study completion until the subject is 18 years]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CorEvitas, LLC — Waltham
Identifiers
NCT: NCT06238765 · CorEvitas-AD-555