MedTrace Logo

A Community-based Assessment of Skin Care, Allergies, and Eczema

NCT03409367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2025-08-15

Study results available
· View outcomes & findings →

Summary

Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.

Conditions

Interventions

OTHER

Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream

Lipid-rich emollient serving as skin barrier

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Eric Simpson, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
63 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2023-09-29
Completion
2024-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409367 on ClinicalTrials.gov