Emollient Skin Care for Eczema

(CASCADE Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily use of an emollient (a moisturizing lotion or cream) from birth can prevent eczema, a skin condition that may lead to other health issues like asthma and allergies. Participants can choose from popular over-the-counter emollients such as Vaseline or CeraVe. The trial invites parents who are the primary caretakers of infants aged 0 to 2 months, have internet access, and can communicate in English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to understanding preventative measures for eczema in infants.

Do I need to stop my baby's current medications for this trial?

The trial information does not specify whether you need to stop your baby's current medications. It seems focused on using emollients for skin care, so it's best to ask the trial coordinators for specific guidance.

What prior data suggests that these emollients are safe for newborns?

Research has shown that over-the-counter skin creams, like those used in this study, are generally easy for people to use without issues. Products such as Vaseline, CeraVe, and Cetaphil are designed to keep the skin moist and protected. For instance, Vaseline often soothes the skin and protects it from irritants or after minor injuries, and most people find it effective.

CeraVe products are specifically formulated to hydrate and calm skin prone to eczema, helping to relieve itching. However, some individuals might not prefer the greasy feel of ointments like Vaseline and CeraVe Healing.

Overall, these skin creams are widely used and recommended for treating dry skin conditions like eczema. They are considered safe and are part of international guidelines for managing atopic dermatitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the emollient-based approach to eczema because it emphasizes daily, full-body application of lipid-rich moisturizers from infancy. Unlike traditional treatments that often rely on medicated creams and ointments only after eczema flares, this proactive method aims to prevent dryness and irritation before it starts. By allowing parents to choose from well-known over-the-counter options like Vaseline, CeraVe, and Cetaphil, this approach is tailored to individual preferences and needs, potentially enhancing adherence and effectiveness.

What evidence suggests that daily emollient use might be an effective treatment for preventing eczema?

This trial will compare the use of daily emollients with natural skin care practices. Studies have shown that using skin moisturizers daily can help prevent atopic dermatitis (AD), a common skin condition. Research indicates that regular application of moisturizers strengthens the skin's barrier, often weak in people with AD. One study found that products like Vaseline or CeraVe effectively and affordably reduce the risk of developing AD. These moisturizers are essential for treating and preventing AD because they keep the skin hydrated and protected. By maintaining a healthy skin barrier, the risk of AD and related allergies or skin issues can be reduced. Participants in this trial will have the option to choose from various emollients, including Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, and Cetaphil cream. ^{5 6 7 8 9}

Who Is on the Research Team?

Eric Simpson

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Daily Emollient Experimental Treatment 1 Intervention

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.

Group II: Natural Skin Active Control 1 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).

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7057622/

an atopic dermatitis primary prevention study using emollients ... This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1555415521002762

Daily Moisturization for Atopic Dermatitis Topical moisturizers are the core treatment for atopic dermatitis (AD), with treatment guidelines recommending at least daily thorough moisturization.

3. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2588412

Cost-effectiveness of Prophylactic Moisturization for Atopic ... The prophylactic use of moisturizers was determined to be cost-effective, with petroleum jelly demonstrating the best cost-benefit ratio ($353/QALY).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7473959/

Efficacy of Nonprescription Moisturizers for Atopic Dermatitis Clinical studies showed that moisturization (typically twice daily) significantly improved the skin barrier in adults and children with AD.

5. aap.org aap.org/en/patient-care/atopic-dermatitis/treatment-of-atopic-dermatitis/?srsltid=AfmBOoqJsYkwbQhockA-1DjDDPm_SBqGnLU1zW8BK6F9sx5V_VHslAvw

Treatment of Atopic Dermatitis Ointments (eg, Aquaphor, Vaseline, CeraVe Healing) are very good moisturizers but because of their greasy feel may not be well tolerated by some ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11546681/

Environmental and behavioral mitigation strategies for ... Consider avoiding products found to have dysbiotic potential including,: Aveeno Eczema Therapy, Curel Hydrotherapy, Eucerin Eczema Relief, Lubriderm ...

7. webmd.com webmd.com/drugs/2/drug-162/petroleum-jelly-topical/details

Petrolatum (Aquaphor, Cerave, Vaseline, and Others) Petrolatum is applied to your skin or lips to help soothe and protect from irritants or after minor injuries. It is usually well tolerated.

8. cerave.com cerave.com/skincare/eczema

Products for Eczema-Prone Skin CeraVe's eczema creams and products for eczema-prone skin are formulated to help hydrate and soothe skin while providing temporary relief from itching.

9. aap.org aap.org/en/patient-care/atopic-dermatitis/treatment-of-atopic-dermatitis/?srsltid=AfmBOoqESEzlJdcghT9my-pEaQ-2REc59L31kMLvCg-nX4tPxSQXlN8L

Treatment of Atopic Dermatitis Ointments (eg, Aquaphor, Vaseline, CeraVe Healing) are very good moisturizers but because of their greasy feel may not be well tolerated by some ...