What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids like fluticasone propionate and skin barrier repair creams such as Epiceram. The side effects of topical corticosteroids can include skin thinning, stretch marks, and potential systemic absorption leading to hormonal imbalances, especially with prolonged use. Skin barrier repair creams like Epiceram are generally well-tolerated, but some patients may experience mild irritation or allergic reactions. It is important to monitor for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

For the treatment of Atopic Dermatitis, the FDA has approved various topical corticosteroids, including fluticasone propionate, which is used for its anti-inflammatory properties. Additionally, barrier repair creams such as Epiceram, which contains ceramides to help restore the skin barrier, have been utilized in managing AD. These treatments aim to reduce inflammation and repair the skin barrier, addressing key aspects of the condition.

What other types of research exist?

Promising novel alternatives for Atopic Dermatitis treatment in 2024 include: 1) Dupilumab, a biologic that targets IL-4 and IL-13 pathways, reducing inflammation and improving skin barrier function. 2) Crisaborole, a non-steroidal topical phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation. 3) Tapinarof, a topical aryl hydrocarbon receptor modulating agent (TAMA) with anti-inflammatory and skin barrier repair properties. 4) JAK inhibitors like Ruxolitinib cream, which target Janus kinase pathways to reduce inflammation.

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Barrier Cream

Skin Barrier Cream + Fluticasone Propionate for Eczema

Phase 2

Recruiting

Led By Kari Nadeau, MD PhD

Research Sponsored by Kari Nadeau, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age

Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.

Must not have

A course of antibiotics in infant within 7 days of enrollment

Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a special moisturizing cream and a mild steroid cream can help infants with early signs of eczema. The goal is to see if this treatment can reduce eczema severity and prevent food allergies. The study focuses on very young babies who have dry skin or early eczema symptoms. EpiCeram™ has been previously tested for preventing eczema in infants with a family history of allergic disease.

Who is the study for?

This trial is for children with early onset eczema (atopic dermatitis) by 12 weeks old, in good health, and without severe skin disorders or chronic diseases. Participants must not have known allergies to study creams or their ingredients and be willing to follow the study procedures.

What is being tested?

The trial tests if proactive skin care using a tri-lipid cream (Epiceram), moisturizer, and fluticasone propionate cream can reduce eczema severity and prevent food allergies compared to standard reactive therapy in infants.

What are the potential side effects?

Possible side effects include skin irritation from Epiceram or fluticasone propionate cream, such as redness, itching, or burning sensation. Fluticasone may also cause thinning of the skin if used long-term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin condition or eczema started before I was 12 weeks old.

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My skin condition started before I was 12 weeks old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant received antibiotics within the last week.

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My infant has a chronic condition needing treatment, like heart disease or diabetes.

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My baby weighs less than 3 kilograms.

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I have a severe skin condition other than atopic dermatitis.

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My parents or guardians will not sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of foods each participant is sensitized to

Secondary study objectives

Number of foods each participant is sensitized to

Presence, duration, and severity of dry skin and/or AD by clinical assessment

The per-subject cumulative number of proven Food Allergy

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: Active Intervention arm (proactive treatment)- EpiceramExperimental Treatment2 Interventions

Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).

Group II: Control arm (Standard of care)Active Control1 Intervention

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Epiceram works by restoring the skin's natural barrier function through the replenishment of essential lipids, which helps to retain moisture and protect against irritants and allergens. Fluticasone propionate, a topical corticosteroid, reduces inflammation and suppresses the immune response in the skin, thereby alleviating symptoms such as redness, itching, and swelling. These mechanisms are crucial for Atopic Dermatitis patients as they address both the underlying barrier dysfunction and the inflammatory processes that drive the condition, leading to improved skin health and symptom relief.

A comparison of twice-daily and once-daily administration of fluticasone propionate cream, 0.05%, in the treatment of eczema.Strategies for using topical corticosteroids in children and adults with eczema.A systematic review of evidence based treatments for lichen simplex chronicus.