← Back to Search

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is designed to compare the effectiveness of proactive and reactive treatment methods for atopic dermatitis (AD) in infants. The proactive treatment includes the use of a skin barrier cream or moisturizer and the proactive use of fluticasone propionate cream. The reactive treatment for AD is currently the standard of care and does not include the proactive use of these two products. The aim is to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

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.Check my eligibility
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.See study design
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
Select...
My skin condition or eczema started before I was 12 weeks old.
Select...
My skin condition started before I was 12 weeks old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of foods each participant is sensitized to
Secondary outcome measures
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

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

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.

Find a Location

Who is running the clinical trial?

Kari Nadeau, MD, PhDLead Sponsor
King's College London and Guy's & St. Thomas HospitalUNKNOWN
Kari NadeauLead Sponsor

Media Library

Atopic Dermatitis Clinical Trial 2023: Epiceram Highlights & Side Effects. Trial Name: NCT03742414 — Phase 2
~158 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top