Atopic Dermatitis Clinical Trial
Official title:
CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
Verified date | February 2024 |
Source | CorEvitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 1500 |
Est. completion date | December 31, 2099 |
Est. primary completion date | December 31, 2099 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 15 Years |
Eligibility | 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 dermatology practitioner. 2. Is 12 - 15 years of age at the time of enrollment. 3. Meets one of the following conditions at the time of enrollment: 1. Has started taking a new Enrollment Eligible Medication within 6 months prior to the Enrollment visit. A new medication is a medication that the subject has never taken before. OR 2. Is prescribed a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before. 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. |
Country | Name | City | State |
---|---|---|---|
United States | CorEvitas, LLC | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
CorEvitas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through Study completion until the subject is 18 years | |
Secondary | Percentage of patients with history of comorbidities | Time Frame: at registry enrollment | ||
Secondary | Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD | Score: 0-4, with high score indicating widespread of atopic dermatitis | every 6 months until the subject is 18 years | |
Secondary | 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 | every 6 months until the subject is 18 years | |
Secondary | Atopic dermatitis body surface area (BSA) | every 6 months until the subject is 18 years | ||
Secondary | 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. | every 6 months until the subject is 18 years | |
Secondary | 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 | every 6 months until the subject is 18 years | |
Secondary | Patient reported : Patient global assessments of disease control and severity | This determines the progression & severity of the disease | every 6 months until the subject is 18 years | |
Secondary | 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 | ||
Secondary | Patient reported: Patient Oriented Eczema Measure (POEM) | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Peak pruritus (itch) NRS | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Skin pain NRS | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Fatigue NRS | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Children's Dermatology Life Quality Index (CDLQI) | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Patient Health Questionnaire (PHQ-4) | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Atopic dermatitis control tool (ADCT) | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Asthma Control test | every 6 months until the subject is 18 years | ||
Secondary | Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD) | 6 months until the subject is 18 years |
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