Proactive skin care to prevent eczema and food allergies in infants
SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
This study is testing if a special skin care routine can help infants with eczema avoid developing food allergies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 1 Week to 12 Weeks |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Trial ID | NCT03742414 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to evaluate the effectiveness of proactive skin care in infants at high risk for food allergies who have developed atopic dermatitis by 12 weeks of age. Participants will be randomly assigned to receive either a proactive treatment regimen, which includes a tri-lipid skin barrier cream and fluticasone propionate cream, or standard reactive therapy. The study aims to determine if proactive care can reduce the occurrence and severity of eczema and prevent the development of food allergies. A total of 312 infants will be recruited for this phase 2 trial.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 0-12 weeks who show early signs of dry skin or atopic dermatitis.
Not a fit: Patients who have chronic diseases requiring therapy or severe skin disorders other than atopic dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of eczema and food allergies in high-risk infants.
How similar studies have performed: Previous studies have shown promise in proactive skin care approaches for managing atopic dermatitis, making this a potentially impactful continuation of that research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 4 other locations
- Sean N. Parker Center for Allergy & Asthma Research at Stanford University — Palo Alto, California, United States (Recruiting)
- Division of Pediatric Allergy and Clinical Immunology, National Jewish Health — Denver, Colorado, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kari Nadeau, MD, PhD — Harvard
- Study coordinator: Kari Nadeau, MD, PhD
- Email: knadeau@hsph.harvard.edu
- Phone: 650.867.4592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.