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Emollient

Emollient Skin Care for Eczema (CASCADE Trial)

N/A
Waitlist Available
Led By Eric Simpson, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parent can speak, read, and write in English or Spanish.
Be younger than 18 years old
Must not have
Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
Parent is unwilling or unable to comply with study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights

Summary

This trial will test whether emollient use from birth can prevent atopic dermatitis (a skin condition that often leads to asthma, food allergies, and other disorders) in a community setting.

Who is the study for?
This trial is for parents of infants aged 0-2 months who can communicate in English or Spanish, have internet access, and are patients at participating clinics. Infants with established eczema, adverse reactions to emollients, certain genetic syndromes, or extremely low birth weight cannot participate.
What is being tested?
The study tests if daily use of over-the-counter emollients like Vaseline and CeraVe from birth prevents eczema development in newborns. It's a community-based trial aiming to set new care standards for all newborns.
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions to the ingredients in the emollient products used such as Vaseline or CeraVe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can speak, read, and write in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant has a genetic condition affecting their immune system.
Select...
My parent cannot or will not follow the study's required steps.
Select...
My baby was born weighing less than 2.2 lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of provider-diagnosed AD
Secondary study objectives
AD by Children's Eczema Questionnaire
AD by UK Working Party criteria
Asthma risk
+10 more
Other study objectives
AD risk
Age at onset
Age of initiation
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Daily EmollientExperimental Treatment1 Intervention
Parents assigned to the intervention arm will receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until their infant is 24 months old. Parents will 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.
Group II: Natural SkinActive Control1 Intervention
Parents assigned to the control arm will receive educational materials promoting general infant skin care guidelines only and will be asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,786 Previous Clinical Trials
2,786,358 Total Patients Enrolled
Duke UniversityOTHER
2,424 Previous Clinical Trials
3,064,834 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,210 Previous Clinical Trials
3,156,489 Total Patients Enrolled

Media Library

Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream (Emollient) Clinical Trial Eligibility Overview. Trial Name: NCT03409367 — N/A
Atopic Dermatitis Research Study Groups: Daily Emollient, Natural Skin
Atopic Dermatitis Clinical Trial 2023: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream Highlights & Side Effects. Trial Name: NCT03409367 — N/A
Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream (Emollient) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03409367 — N/A
~174 spots leftby Sep 2025
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