Atopic Dermatitis
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* To be eligible to participate in this registry, an individual must meet all the following criteria: 1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider 2. Is 10 - 15 years of age at the time of enrollment. 3. 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: 1. Is participating or planning to participate in a blinded clinical trial for an AD drug. 2. Is unwilling or unable to provide standing height measurements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AD epidemiology, presentation, natural history, management, and outcomes | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with history of comorbidities | Time Frame: at registry enrollment | — |
| Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD | every 6 months until the subject is 18 years | Score: 0-4, with high score indicating widespread of atopic dermatitis |
| Physician reported: Nail changes due to atopic dermatitis (graduated VAS) | 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 |
| Atopic dermatitis body surface area (BSA) | every 6 months until the subject is 18 years | — |
| Eczema Area and Severity Index (EASI) (calculated) | 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. |
| Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) | 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 |
| Patient reported : Patient global assessments of disease control and severity | every 6 months until the subject is 18 years | This determines the progression \& severity of the disease |
| Physician reported : Pubertal Progression: Tanner Staging Assessment | 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) | every 6 months until the subject is 18 years | — |
| Patient reported: Peak pruritus (itch) NRS | every 6 months until the subject is 18 years | — |
| Patient reported: Skin pain NRS | every 6 months until the subject is 18 years | — |
| Patient reported: Fatigue NRS | every 6 months until the subject is 18 years | — |
| Patient reported: Children's Dermatology Life Quality Index (CDLQI) | every 6 months until the subject is 18 years | — |
| Patient reported: Patient Health Questionnaire (PHQ-4) | every 6 months until the subject is 18 years | — |
| Patient reported: Atopic dermatitis control tool (ADCT) | every 6 months until the subject is 18 years | — |
| Patient reported: Asthma Control test | every 6 months until the subject is 18 years | — |
| Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD) | 6 months until the subject is 18 years | — |
Countries
United States
Outcome results
None listed