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Published in: Trials 1/2020

01-12-2020 | Atopic Dermatitis | Study protocol

A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients—protocol for a randomized controlled trial

Authors: Brian Eichner, Le Ann C. Michaels, Kelsey Branca, Katrina Ramsey, Julie Mitchell, Cynthia D. Morris, Lyle J. Fagnan, Rowena J. Dolor, Nancy Elder, David L. Hahn, Donald E. Nease, Jodi Lapidus, Ricardo Cibotti, Julie Block, Eric L. Simpson

Published in: Trials | Issue 1/2020

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Abstract

Background

Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of developing AD, preventative application of lipid-rich emollients may reduce the risk of developing AD. This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial in the primary care setting.

Methods

Infant–parent dyads are recruited from a primary care practice participating through one of four practice-based research networks in Oregon, Colorado, Wisconsin, and North Carolina. Eligible dyads are randomized to the intervention (daily use of lipid-rich emollient) or the control (no emollient) group (n = 625 infants in each) and are followed for 24 months. The primary outcome is the cumulative incidence of physician-diagnosed AD and secondary outcomes include caregiver-reported measures of AD and development of other atopic diseases. Data collection occurs via chart review and surveys, with no study visits required. Data will be analyzed utilizing intention-to-treat principles.

Discussion

AD is a common skin condition in infants that affects quality of life and is associated with the development of other atopic diseases. If a safe intervention, such as application of lipid-rich emollients, in the general population effectively decreases AD prevalence, this could alter the guidance given by providers regarding routine skin care of infants. Because of the pragmatic design, we anticipate that this trial will yield generalizable results.

Trial registration

ClinicalTrials.​gov: NCT03409367. Registered on 11 February 2018.
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Metadata
Title
A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients—protocol for a randomized controlled trial
Authors
Brian Eichner
Le Ann C. Michaels
Kelsey Branca
Katrina Ramsey
Julie Mitchell
Cynthia D. Morris
Lyle J. Fagnan
Rowena J. Dolor
Nancy Elder
David L. Hahn
Donald E. Nease
Jodi Lapidus
Ricardo Cibotti
Julie Block
Eric L. Simpson
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4150-5

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