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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
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 change from baseline scorad at 1, 2 and 3 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 ~change from baseline scorad at 1, 2 and 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline scorad at 1, 2 and 3 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
Cumulative number of challenge-proven food allergy
Secondary outcome measures
Scoring Atopic Dermatitis (SCORAD)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Active Intervention arm (proactive treatment)- MoisturizerExperimental Treatment2 Interventions
Participants will receive proactive sequential skin care with the twice-daily use of a moisturizer. Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).
Group II: 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 III: 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moisturizer
2008
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

Kari NadeauLead Sponsor
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,340,480 Total Patients Enrolled
Harvard School of Public Health (HSPH)OTHER
272 Previous Clinical Trials
16,304,150 Total Patients Enrolled

Media Library

Atopic Dermatitis Clinical Trial 2023: Epiceram Highlights & Side Effects. Trial Name: NCT03742414 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What skin conditions does Tri-lipid skin barrier cream (Epiceram) help alleviate?

"Tri-lipid skin barrier cream (Epiceram) is most effective in the treatment of rhinorrhoea but can also be used to treat seasonal allergic rhinitis, chronic bronchitis, and chronic obstructive airway disease."

Answered by AI

FDA approval status of Tri-lipid skin barrier cream (Epiceram)?

"While Phase 2 trials provide less evidence than later phases, there is still data suggesting that Tri-lipid skin barrier cream (Epiceram) is safe."

Answered by AI

Are the age requirements for this clinical trial flexible?

"Following the age restrictions set out in the eligibility criteria, the minimum age for enrollment in this trial is 1 Week old, with the maximum age being 12 Weeks old."

Answered by AI

Might I be eligible to lend my body to this experiment?

"This study is seeking 875 infants between 1 week and 12 weeks old who have eczema. In addition to being within this age range, participants must also have no known allergies to the study medications, be in good general health, and be willing to comply with all study procedures."

Answered by AI

Is the Tri-lipid skin barrier cream (Epiceram) a new medication?

"Epiceram, a tri-lipid skin barrier cream, was first studied in 2007 by Arthur F. Gelb Medical Corporation. As of now, 567 clinical trials have been completed, with 19 more underway. A large proportion of these studies are based in Mountain View, California."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Sean N Parker Center for Allergy and Asthma Research, Department of Medicine, Division of Pulmonary & Critical Care Medicine Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Sean N Parker Center for Allergy and Asthma Research, Department of Medicine, Division of Pulmonary & Critical Care Medicine Stanford University School of Medicine: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Seal, Stopping Eczema and Allergy Study
Kari Nadeau 2021. "Seal, Stopping Eczema and Allergy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03742414.
All > Seborrheic Dermatitis > Atopic Dermatitis
~379 spots leftby Jul 2026
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