Parent-directed remote identification and severity assessments enabling decentralized trials in atopic dermatitis

NIH RePORTER · NIH · R01 · $402,616 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY Recent studies reveal up to half of children with childhood onset atopic dermatitis (AD) may remit over time, whereas in others, AD worsens with age. AD in childhood often heralds the development of subsequent comorbidities including asthma, food allergies, skin infections and neurodevelopmental disorders. It is not known whether the timing or type of treatment for AD alters the natural course of the disease or modifies the risk of comorbidity development. Therapeutic strategies that prevent or alter the natural course of AD represent the highest priority research gap as identified by the International Eczema Council in 2021. This gap aligns with the overarching long-term goal of our research team to identify and test interventions that prevent the overall burden of AD and comorbidities in broad and diverse communities. The overall objective of this application, as a critical step towards our long-term goal, is to develop tools that facilitate patient-centered decentralized clinical trials investigating the role of early intervention on disease course and comorbidity risk. We will achieve this objective by completing the following aims: Aim 1) Determine the feasibility and accuracy of identifying new-onset AD remotely in a community-based high-risk pediatric cohort using parent/guardian-reported validated diagnostic criteria with photographic documentation using a novel mobile application; and Aim 2) Determine the accuracy of parent/guardian report of AD severity using an image-based assessment of skin lesions in order to efficiently measure disease severity over time. These tools will be utilized in future decentralized trials of early therapeutic intervention. Our established community-based clinical trial network, central study team infrastructure, and decentralized study design expertise allow for increased efficiency in enrollment and improved generalizability of results as compared to traditional approaches – two factors that will ensure the success of this proposed project.

Key facts

NIH application ID
10800448
Project number
1R01AR082107-01A1
Recipient
OREGON HEALTH & SCIENCE UNIVERSITY
Principal Investigator
Eric L Simpson
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$402,616
Award type
1
Project period
2024-02-16 → 2026-01-31