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.
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 Type
OBSERVATIONAL
Enrollment
1,500
CorEvitas, LLC
Waltham, Massachusetts, United States
RECRUITINGAD 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 until the subject is 18 years
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
Score: 0-4, with high score indicating widespread of atopic dermatitis
Time frame: 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
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)
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 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
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Time frame: 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
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