Seal, Stopping Eczema and Allergy Study
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).
Conditions:
🦠 Eczema, Infantile 🦠 Eczema 🦠 Atopic Dermatitis Eczema 🦠 Atopic Dermatitis
🗓️ Study Start (Actual) 30 June 2021
🗓️ Primary Completion (Estimated) 31 May 2027
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 312
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Palo Alto, California, United States
📍 Denver, Colorado, United States
📍 Chicago, Illinois, United States
📍 Cincinnati, Ohio, United States
📍 London, United Kingdom

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • 1. Infants \<3kg body weight
    • 2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
    • 3. 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
    • 4. Parents or guardians unwilling to sign consent
    • 5. Current participant or participation since birth in any interventional study
    • 6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
    • 7. A course of antibiotics in infant within 7 days of enrollment
    • 8. Any known food allergies
Ages Eligible for Study: 1 Week to 12 Weeks (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 October 2018
  • First Submitted that Met QC Criteria 13 November 2018
  • First Posted 15 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 May 2024
  • Last Update Posted 10 May 2024
  • Last Verified October 2023