Active — Not RecruitingPhase 2

Seal, Stopping Eczema and Allergy Study

United States, United Kingdom398 participantsStarted 2021-06-30

Plain-language 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) 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).

Who can participate

Age range1 Week – 12 Weeks

SexALL

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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

What they're measuring

number of foods each participant is sensitized to

Timeframe: 2 years

Trial details

NCT IDNCT03742414

SponsorKari Nadeau, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31

View on ClinicalTrials.gov More Eczema, Infantile trials