Seal, Stopping Eczema and Allergy Study

Launched by KARI NADEAU, MD, PHD · Nov 13, 2018

Keywords

ClinConnect Summary

The Seal, Stopping Eczema and Allergy Study is a clinical trial aimed at helping babies with eczema, also known as atopic dermatitis. This study is looking at how different types of skin care routines can help reduce the severity of eczema and, importantly, may prevent food allergies later on. In this trial, some children will use a specific skin barrier cream and a mild steroid cream twice a day, while others will receive standard treatment for eczema. The goal is to see which approach works better to help manage eczema in babies.

To be eligible for this study, children must be between 7 weeks and 84 weeks old and have developed visible dry skin or eczema by 12 weeks of age. Parents should be willing to follow the study procedures and ensure their child is generally healthy. However, infants with certain health issues, those who are too small, or those who have known food allergies would not be able to participate. If families decide to join, they can expect to follow a specific skin care plan and attend regular check-ups to monitor their child's skin and overall health during the study.

Gender

ALL

Eligibility criteria

• 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