Atopic dermatitis is a chronic inflammatory skin condition affecting up to 10-20% of children worldwide. Children who develop atopic dermatitis are at increased risk for the development of food allergy, asthma, allergic rhinitis, and skin infections. Affected children suffer from inflamed pruritic skin lesions and experience more disturbed sleep, difficulty in school, and behavioral issues compared to healthy controls. Because of the high prevalence and the impact of the disease on children and families, identifying effective prevention strategies is an important public health goal. Despite over 40 years of research, primarily focused on allergen- avoidance strategies, no consistently effective prevention strategy has emerged. The long-term goal of our research program is to develop novel prevention strategies that reduce the burden of atopic dermatitis and other atopic diseases in large populations. Recent breakthroughs in our understanding of the pathogenesis of atopic dermatitis, especially regarding the role of the skin barrier in disease initiation, creae an opportunity for a novel approach to AD prevention. Our central hypothesis is that emollient therapy from birth can prevent or delay the onset of atopic dermatitis and potentially reduce the risk of allergic sensitization. Our promising preliminary data support the need for a larger clinicl trial of emollient therapy for atopic dermatitis prevention. We propose a pragmatic randomized controlled trial utilizing an established community-based research network. Using a pragmatic trial design and community-based approach allows for the results to be broadly generalizable reducing the barriers for subsequent dissemination and implementation into large populations. To implement such a trial, a 24-month planning period will be needed. We propose the following specific aims for this 24 month planning period: 1) Develop a study protocol for a UM1 proposed community-based clinical trial of atopic dermatitis prevention using emollient therapy, 2) Perform model recruitment to assess rate of accrual and parental willingness to participate across networks and representative practices, and 3) Using the Data Coordinating Center for this study, develop training programs for participating sites, a data management plan, and an adverse event reporting plan in support of a UM1 proposal. Given the experience and expertise of our multi-disciplinary team, we expect to successfully complete all aims of this proposal in the 24-month award period. The objectives of this proposal are in direct alignment with disease prevention goals of the NIH, NIAMS, and the Healthy People 2020 initiative as well as the NIH CTSA Roadmap initiative promoting community-engaged research. The expected results from the UM1 project would represent a major public health breakthrough with the potential for reducing the atopic disease burden on a global scale.
The proposed research is relevant to the NIH mission because its primary objective is to prevent atopic dermatitis, a disease with a worldwide distribution and high prevalence. In addition, the strategy is a simple, low-cost, and safe intervention that may also reduce the risk of children developing other diseases like food allergy. The strategy under investigation is one that could be readily implemented into current medical practice and could create an immediate positive public health impact.