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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Latifa
Rahman
Latifa.Rahman@gstt.nhs.uk
gemma
Deutsch
Gemma.deutsch@kcl.ac.uk
Prof
Gideon
Lack
gideon.lack@kcl.ac.uk
Dermatitis and eczemaOther and unspecified effects of external causes
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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 750 infants aged 0-10 weeks who have already developed eczema/atopic disease (AD). 375 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 375 children in the control group will receive standard eczema care. After 3 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 two US sites (Stanford and Denver).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Device;
You can take part if:
You may not be able to take part if:
Exclusion criteria include: 1. Infants that are small for gestational age 2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects) 3. Parent/ guardian(s) unwilling to give consent 4. Current participant or participation since birth in any interventional study 5. Investigator considers that the participant or parent/guardian would be unsuitable for inclusion in the study
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Miss
Latifa
Rahman
Latifa.Rahman@gstt.nhs.uk
gemma
Deutsch
Gemma.deutsch@kcl.ac.uk
Prof
Gideon
Lack
gideon.lack@kcl.ac.uk
The study is sponsored by Harvard University and funded by National Institutes of Health (NIH), United States .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 50503
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