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

NCT06238765 | Recruiting

• 1 other identifier: CorEvitas-AD-555
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

• Physician reported: Nail changes due to atopic dermatitis (graduated VAS)

  every 6 months until the subject is 18 years

• 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

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects can enroll as early as age 12 and will be followed until the age of 18; therefore, the maximum duration a subject can be enrolled is \< 6 years.

You may qualify if:

• 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 dermatology practitioner.
• Is 12 - 15 years of age at the time of enrollment.
• Meets one of the following conditions at the time of enrollment:
• 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.
• Is prescribed a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in the registry:
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• Is participating or planning to participate in a blinded clinical trial for an AD drug.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 2, 2024
• Study Start: December 2, 2023
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

US (1)