Registry for adolescents with atopic dermatitis to assess treatment safety and effectiveness
CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
This study is trying to see how safe and effective different treatments are for teenagers aged 12 to 15 with moderate to severe eczema.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 12 Years to 15 Years |
| Sex | All |
| Sponsor | CorEvitas Research network |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT06238765 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to create a cohort of adolescents aged 12 to 15 diagnosed with moderate to severe atopic dermatitis (AD) to evaluate the long-term safety and effectiveness of various AD treatments. Approximately 1500 subjects will be recruited from 75 clinical sites across North America and select European countries. Data collected will include patient-reported outcomes, clinician-reported outcomes, and information on comorbidities and adverse events, which will help inform clinical decision-making and ongoing risk-benefit evaluations by drug manufacturers and regulators.
Who should consider this trial
Good fit: Ideal candidates for this registry are adolescents aged 12 to 15 who have been diagnosed with moderate to severe atopic dermatitis and are starting a new medication.
Not a fit: Patients currently participating in a blinded clinical trial for an AD drug will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of treatments for adolescents with atopic dermatitis, leading to improved management strategies.
How similar studies have performed: Other observational studies have successfully characterized treatment outcomes in atopic dermatitis, suggesting that this approach is both viable and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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:
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1. Is participating or planning to participate in a blinded clinical trial for an AD drug.
Where this trial is running
Waltham, Massachusetts
- CorEvitas, LLC — Waltham, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.