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

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, physicianblinded trial in the primary care setting. Methods: Infant-parent dyads are recruited from a primary care practice participating through one of four practicebased 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.

Skincare interventions in infants for preventing eczema and food allergy: A cochrane systematic review and individual participant data meta‐analysis

“…Two trials included in the IPD classified as “complex emollients” used a ceramide base emollient. We await the results of two further ongoing trials of “complex" ceramide‐dominant emollients, which should report later next year 25,26 …”

“…We await the results of two further ongoing trials of "complex" ceramide-dominant emollients, which should report later next year. 25,26 The evidence for food allergy prevention is sparse, with only one study reporting this outcome mainly because there is significant difficulty in measuring food allergy outcomes in prevention studies. Oral food challenges, necessary to firmly document food allergy, are costly and time-consuming and may not be acceptable to parents.…”

Spontaneously Resolved Atopic Dermatitis Shows Melanocyte and Immune Cell Activation Distinct From Healthy Control Skin

“…However, the exact mechanisms of disease persistence are still unknown, and there is no biomarker available that can predict whether a child will outgrow the disease. Despite current attempts to prevent AD in at-risk children using intensified emollient treatment from birth on ( 9 , 10 ), there is a lack of disease-modifying therapies inducing permanent remission once AD is established, as opposed to other atopic diseases such as allergic rhinoconjunctivitis or asthma, which can often be modulated by immunotherapy ( 11 ). Thus, a better understanding of mechanisms guiding the natural course of the disease is an unmet medical need.…”

The Importance of Primary Care Research in Understanding Health Inequities in the United States

“…Because of its comprehensiveness, studying health inequities in the context of primary care allows for the use of multiple paradigms and methodologic approaches to understanding almost any state of health, disease, social challenge, or societal circumstance patients might face. Further, while most research methods can be used in primary care, some methods such as pragmatic trials, 11,12 dissemination and implementation research, 13 and patientinvestigator partnerships 14 are especially appropriate for primary care settings. Primary care delivery will not solve inequity alone, but observational and interventional research in the primary care setting is an essential and overlooked piece of the science to understand and reduce health inequity.…”