SEAL
Research type
Research Study
Full title
SEAL (STOPPING ECZEMA AND ALLERGY) STUDY: PREVENT THE ALLERGIC MARCH BY ENHANCING THE SKIN BARRIER
IRAS ID
256248
Contact name
Gemma Deutsch
Contact email
Sponsor organisation
Harvard University
Eudract number
2021-003599-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
256248, IRAS Project ID
Duration of Study in the UK
5 years, 9 months, 31 days
Research summary
Food allergy (FA) is an epidemic among children throughout the world. The overall objective of the SEAL (Stopping Eczema and ALlergy) Study is to prevent allergy by enhancing the skin barrier with proactive skin care utilising the combination of skin emollient early in life with topical anti-inflammatory agents as required to decrease epicutaneous allergen sensitisation and FA. The effectiveness of this prevention strategy will be monitored by novel measures of skin barrier function and the emergence of protective immune responses in infants and young children benefiting from this novel preventative approach. SEAL is a randomised controlled trial and will recruit a total of 312 infants aged 0-12 weeks who have already developed eczema/atopic disease (AD). 116 children in the intervention group will follow a proactive treatment regimen, including twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, and 116 children in the control group will receive standard eczema care. There will be 80 participants in the Aveeno and proactive use of fluticasone propionate cream (AFP) arm of the study; this arm ceased recruitment early but participants will continue to follow the protocol until study completion. After 2 years of follow-up participants will be assessed for the cumulative number of food allergies they have developed, by undergoing oral food challenges. This will be a multi-site study with one UK site, i.e. the Paediatric Allergy Research Group based at Evelina London, and four US sites (Stanford, Denver, Chicago and Cincinnati).
REC name
HSC REC B
REC reference
21/NI/0151
Date of REC Opinion
24 Dec 2021
REC opinion
Further Information Favourable Opinion