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

NCT03409367 | Completed Results DMC

• 1 other identifier: 1R01AR071057-01A1
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 4

Brief 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

Atopic Dermatitis; Atopic Disorders; Eczema; Atopic Eczema

Keywords

Prevention; Emollient; Pragmatic clinical trial

Outcome Measures

Primary Outcomes (1)

• Provider-diagnosed Atopic Dermatitis

  The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.

  up to 24 months

Secondary Outcomes (16)

• Parent Report of Atopic Dermatitis

  up to 24 months

• Atopic Dermatitis by UK Working Party Criteria

  up to 24 months

• Atopic Dermatitis by Children's Eczema Questionnaire

  up to 24 months

• Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart

  up to 24 months

• Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal)

  Up to 24 months

Other Outcomes (2)

• Provider-diagnosed Atopic Dermatitis - Low-risk Population

  up to 24 months

• Provider-diagnosed Atopic Dermatitis - High-risk Population

  up to 24 months

Study Arms (2)

Daily Emollient

EXPERIMENTAL

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.

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

Natural Skin

NO INTERVENTION

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).

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

Daily Emollient

Eligibility Criteria

• Age: 1 Day - 63 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent can provide electronic signed and dated informed consent form.
• Parent is willing and able to comply with all study procedures for the duration of the study.
• Parent is a primary caretaker of an infant 0 to 2 months of age.
• Parent is 18 years of age or older at time of consent.
• Parent can speak, read, and write in English or Spanish.
• Parent has a valid e-mail address or phone that can receive text messages
• Parent has reliable access to the internet.
• Infant is a patient of a participating Meta-LARC clinic site at the time of consent.

You may not qualify if:

• Infant was born at less than 25 weeks gestational age.
• Infant has established eczema as diagnosed by the primary healthcare provider at clinic site of enrollment per parent report.
• Infant has known adverse reaction to petrolatum-based emollients.
• Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
• Infant has extremely low birth weight (less than 1000g or 2.2 lbs at birth).
• Infant has a sibling enrolled in the study.
• Parent is unwilling or unable to comply with study procedures.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Wisconsin, Madison: collaborator
• University of Colorado, Denver: collaborator
• Duke University: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (4)

University of Colorado-Denver

Denver, Colorado, 80045, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53175, United States

Location

Related Publications (2)

• Simpson EL, Michaels LC, Ramsey K, Fagnan LJ, Nease DE, Henningfield M, Dolor RJ, Lapidus J, Martinez-Ziegenfuss X, Vu A, Ferrara L, Zuckerman KE, Morris CD, Williams HC; CASCADE Consortium. Emollients to Prevent Pediatric Eczema: A Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 23;161(9):957-65. doi: 10.1001/jamadermatol.2025.2357. Online ahead of print.

  PMID: 40699587 DERIVED

• Eichner B, Michaels LAC, Branca K, Ramsey K, Mitchell J, Morris CD, Fagnan LJ, Dolor RJ, Elder N, Hahn DL, Nease DE, Lapidus J, Cibotti R, Block J, Simpson EL. 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. Trials. 2020 Mar 4;21(1):243. doi: 10.1186/s13063-020-4150-5.

  PMID: 32131885 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Oregon Health & Science University

michaell@ohsu.edu

503-764-8544

Study Officials

• Eric Simpson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible blind dyads to the intervention. Administering a placebo emollient is impossible as there are no active ingredients in the emollient and using an emollient that has no barrier improvement properties may irritate the skin. The clinician completing the final assessment will be a blinded assessor. Clinic staff will not be informed of participant enrollment or study arm. Parents will be instructed not to disclose their treatment group to clinic staff. Clinicians and clinic staff will direct participants to follow skin care recommendations as described by the study materials. Blinded researchers will be responsible for health record review to collect the primary outcome. At completion of health record review, researchers will complete a form measuring whether the assessor became unblinded while reviewing the record.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a pragmatic, multi-site, randomized community-based trial in which dyads of a parent or legal guardian ("parent") and an infant age 0 to 2 months are enrolled. Participating dyads are randomly assigned to receive lipid-rich emollient with web-based instructions for daily use to infants plus routine skin care instructions (every day moisturizer group) or routine skin care instructions alone (natural skin group). Both groups will receive e-mail and text message reminders to follow protocol instructions based on their group allocation until the infant reaches 24 months old.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 24, 2018
• Study Start: July 16, 2018
• Primary Completion: September 29, 2023
• Study Completion: January 31, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Supporting information will be shared per NIAMS guidelines

Locations

US (4)