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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Oregon Health and Science University
Study ID
NCT03409367
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 63 Days
Healthy Volunteers
Accepted

Interventions

  • Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream — OTHER
    Lipid-rich emollient serving as skin barrier

Study Details

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.

Key Dates

Start date
Jul 16, 2018
Status verified
Aug 2025
Primary completion
Sep 29, 2023
Completion
Jan 31, 2024

Study Design

Enrollment
1,260 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Daily Emollient
    Parent-infant dyads assigned to the intervention arm receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until the infant is 24 months old. Parents select one of five emollients to be mailed to the dyad's home at enrollment and approximately every six months for the duration of the study. These emollients include (1) CeraVe Healing Ointment, (2) Vaseline, (3) Cetaphil cream, (4) CeraVe cream, and (5) Vanicream.
  • No Intervention: Natural Skin
    Parent-infant dyads assigned to the control arm receive educational materials promoting general infant skin care guidelines only and are asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).

Primary Outcome Measure

Provider-diagnosed Atopic Dermatitis [ Time Frame: up to 24 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado-DenverDenverColorado80045-
Duke UniversityDurhamNorth Carolina27705-
Oregon Health & Science UniversityPortlandOregon97239-
University of Wisconsin-MadisonMadisonWisconsin53175-

Find similar trials in Denver, CO

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Colorado-Denver· Denver, CODuke University· Durham, NCOregon Health & Science University· Portland, ORUniversity of Wisconsin-Madison· Madison, WI

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