Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05407012 |
| Other study ID # |
RE19787 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2024 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
King's College London |
| Contact |
Stuart Jones |
| Phone |
0207 848 4506 |
| Email |
stuart.jones[@]kcl.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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:
1. Establish if peanut allergen components can pass into human skin through regular massage
using the peanut protein-containing extract.
2. Clarify whether this effect is amplified in those with an impaired skin barrier (AD and
dry skin vs healthy controls).
3. Assess whether peanut protein components can be detected in interstitial skin fluid
(ISF) using a suction device.
4. Test whether peanut protein components present in ISF are able to induce activation of
basophils in blood of peanut allergic donors.
5. Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior
use of a barrier enhancing cream.
Description:
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:
- Peanut proteins pass into the skin via the appendages to trigger an immune response.
- Skin stretching that occurs during massage opens up the skin appendages allowing more
peanut protein into the skin and leads to dendritic cell activation and induction of T
helper 2 cell response.
- Co-administration of peanut proteins and an oil to the skin increases allergenicity.
- Skin barrier impairment and inflammation (AD) increases allergenicity.
Test novel approaches to peanut allergy prevention whereby:
- Modifications in peanut processing can reduce allergen exposure via the skin.
- Meticulous hand hygiene reduces skin contamination with peanut protein.
- Application of a barrier enhancing cream can strengthen the skin barrier, in particular
in those with atopic dermatitis, and reduce the risk of transcutaneous sensitisation
further.
