Emollient Skin Care for Eczema

(CASCADE Trial)

Recruiting at 3 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Eczema, Immunodeficiency, Low birth weight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

1250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eric Simpson

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

Inclusion Criteria

Parent is willing and able to comply with all study procedures for the duration of the study.

I have an email or a phone number that can receive texts.

I can speak, read, and write in English or Spanish.

Exclusion Criteria

The baby has had a bad reaction to creams with petrolatum in the past.

My infant has a genetic condition affecting their immune system.

The baby was born before 25 weeks of pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Daily full-body emollient application starting in the first 2 months of life to prevent atopic dermatitis

24 months

Routine visits as part of primary care

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Quarterly contacts or annual questionnaires

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Daily Emollient Experimental Treatment 1 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 Skin Active Control 1 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).

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+