NCT05407012

Brief 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. 1.Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract.
  2. 2.Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls).
  3. 3.Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device.
  4. 4.Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors.
  5. 5.Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

May 26, 2022

Last Update Submit

May 3, 2024

Conditions

Allergy;FoodFood Allergy PeanutPathways and Sources of Exposure

Keywords

AllergyFood safetyPublic healthDermatologyFood manufacture

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (2)

  • Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.

    8 weeks

  • Raised transepidermal water loss.

    8 weeks

Other Outcomes (1)

  • Assess skin barrier function measures (skin surface pH).

    8 weeks

Study Arms (2)

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.

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.

Interventions

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;

Intervention of the barrier enhancing preparation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Population-Based Dermatology Research

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Food HypersensitivityPeanut HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System DiseasesNut and Peanut Hypersensitivity

Study Officials

  • Carsten Flohr

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart Jones

CONTACT

0207 848 4506stuart.jones@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 7, 2022

Study Start

April 5, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)