Allergy;FoodTRANS-FOODSNCT05407012
TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
A study testing Application of the barrier enhancing preparation. in people with Allergy;Food and Food Allergy Peanut, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy;Food, Food Allergy Peanut, Pathways and Sources of Exposure
- What is being tested?
- Application of the barrier enhancing preparation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthy volunteers (50% of the cohort), and adults with dry skin and AD (fulfilling the refined Hanifin and Rajka criteria, 50% of the cohort).
- Willingness to apply the study intervention and to not use any other topical preparations over theforearms during the study period.
Who cannot join
- History of peanut allergy.
- Positive skin prick test to peanut (>0 mm).
- No regular consumption of peanut products.
- Widespread AD, in particular if this involves the test sites of the forearms.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Unit for Population-Based Dermatology Research
London, SE1 7EH
Preeti Kaur Khurana, MSc, +44 (0) 20 7188 7188 ext. 57716, preeti.k.khurana@kcl.ac.uk
About this study
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:
- Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract.
- Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls).
- Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device.
- Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors.
- Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.
Read the detailed 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.
- Being tested
- Application of the barrier enhancing preparation.
- Keywords
- Allergy, Food safety, Public health, Dermatology, Food manufacture
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the barrier enhancing preparation.Other
Application of the barrier enhancing preparation around 30 minutes before application of the peanut protein extract +/- massage after extract application;
| Study group | Role | What they receive |
|---|---|---|
| Intervention of the barrier enhancing preparation | Experimental | Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application. Receives: Other: Application of the barrier enhancing preparation. |
| Absence of the barrier enhancing preparation | No intervention | Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
Raised transepidermal water loss.
Raised transepidermal water loss.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start5 Apr 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergy;FoodStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, Institut Curie, Charite University, Berlin, Germany, Levantine UK
- Responsible party
- Sponsor
- Investigators
- Carsten Flohr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407012
- Sponsor's protocol ID
- RE19787
- Acronym
- TRANS-FOODS
- Status last verified
- May 2024
- First submitted
- 26 May 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khurana P, Murryam S, Gilman H, Phillips K, Benaouda F, Lawrence KP, Aly M, Santos AF, Jones SA, Flohr C. TRANS-FOODS study protocol: an observer-blinded, randomized controlled study to assess transcutaneous sensitization to peanut protein in adults with and without atopic dermatitis. Skin Health Dis. 2026 Jun 25;6(4):424-430. doi: 10.1093/skinhd/vzag046. eCollection 2026 Aug.
PubMed 42539976
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
- ClinicalTrials.gov ID
- NCT05407012
- Acronym / sponsor ID
- TRANS-FOODS / RE19787
- Keywords
- Allergy, Food safety, Public health, Dermatology, Food manufacture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, Institut Curie, Charite University, Berlin, Germany, Levantine UK
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract.
- Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls).
- Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device.
- Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors.
- Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention of the barrier enhancing preparation | Experimental | 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. |
| Absence of the barrier enhancing preparation | No intervention | –Dry skin or atopic dermatitis or healthy skin; application of the peanut protein extract +/- massage after extract application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult healthy volunteers (50% of the cohort), and adults with dry skin and AD (fulfilling the refined Hanifin and Rajka criteria, 50% of the cohort).
- Willingness to apply the study intervention and to not use any other topical preparations over theforearms during the study period.
Key exclusion criteria (4 listed)
- History of peanut allergy.
- Positive skin prick test to peanut (>0 mm).
- No regular consumption of peanut products.
- Widespread AD, in particular if this involves the test sites of the forearms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the barrier enhancing preparation.Application of the barrier enhancing preparation around 30 minutes before application of the peanut protein extract +/- massage after extract application; | Other | Intervention of the barrier enhancing preparation |
Primary outcome
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
Time frame: 8 weeks
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved 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
Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
2 secondary outcomes
Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.
Time frame: 8 weeks
Raised transepidermal water loss.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 42539976Khurana P, Murryam S, Gilman H, Phillips K, Benaouda F, Lawrence KP, Aly M, Santos AF, Jones SA, Flohr C. TRANS-FOODS study protocol: an observer-blinded, randomized controlled study to assess transcutaneous sensitization to peanut protein in adults with and without atopic dermatitis. Skin Health Dis. 2026 Jun 25;6(4):424-430. doi: 10.1093/skinhd/vzag046. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Flohr principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of the barrier enhancing preparation. in people with Allergy;Food and Food Allergy Peanut, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stuart Jones (0207 848 4506, stuart.jones@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.