Seal, Stopping Eczema and Allergy Study

  • STATUS
    Recruiting
  • End date
    Jul 14, 2027
  • participants needed
    875
  • sponsor
    Kari Christine Nadeau, MD, PhD
Updated on 14 July 2022
food allergy
eczema
dry skin
topical agents
epiceram

Summary

This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.

The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Details
Condition Eczema, Infantile, Eczema, Atopic Dermatitis Eczema, Atopic Dermatitis
Treatment Standard of Care, Moisturizer, Tri-lipid skin barrier cream (Epiceram), Fluticasone propionate Cream 0.05%
Clinical Study IdentifierNCT03742414
SponsorKari Christine Nadeau, MD, PhD
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age
Stated willingness to comply with all study procedures and availability for the duration of the study
In good general health as evidenced by medical history
No known adverse reaction to any of the study medications, their components or excipients

Exclusion Criteria

Infants <3kg body weight
Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
Parents or guardians unwilling to sign consent
Current participant or participation since birth in any interventional study
Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
A course of antibiotics in infant within 7 days of enrollment
Any known food allergies
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