An interventional study of Application of the barrier enhancing preparation. in Allergy;Food, Food Allergy Peanut and Pathways and Sources of Exposure, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by King's College London · Not applicable, Interventional, and Other
This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to:
The study aims to understand how peanut processing methods and peanut co-administration with oils, as is standard during the industrial processing of peanuts, influences the development of peanut allergy through the skin.
Cutaneous exposure of allergens is a crucial, but hitherto under explored route of food sensitisation, that if understood could lead to the development of translatable strategies to prevent food allergy. Food processors require a greater understanding of how allergen exposure cause allergy so that they can adapt their processing methods to counteract these exposure processes. Furthermore, this proposed research aligns with on-going efforts across Europe to address the increasing problems associated with food allergy but it is unique in that it focuses on cutaneous allergen exposure, which is a field in desperate need of more systematic study.
The assembled team of investigators (from the UK, Germany and France) joined by a peanut industry partner (Levantine) and patient and consumer representatives will aim to address the following hypotheses:
Understanding the mechanisms by which:
Test novel approaches to peanut allergy prevention whereby:
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Compared within Peanut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.
Other: Application of the barrier enhancing preparation.
Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application.
Application of the barrier enhancing preparation around 30 minutes before application of the peanut protein extract +/- massage after extract application;
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
Time frame: 8 weeks
Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
Time frame: 8 weeks
Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
Time frame: 8 weeks
Raised transepidermal water loss.
Raised transepidermal water loss.
Time frame: 8 weeks
Assess skin barrier function measures (skin surface pH).
Assess skin barrier function measures (skin surface pH).
Time frame: 8 weeks
Plan to share: No
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