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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

No Placebo-Only Group

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

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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:

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My infant has a genetic condition affecting their immune system.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 4Eligibility criteria met