Investigating Immune Mechanisms in Atopic Eczema

April 27, 2021 updated by: University College, London

Investigating the Role of Skin Resident T Cells in Atopic Eczema and Responses to Antigen Challenge

The aim of this study is to investigate the mechanisms behind the immune dysfunction that occurs in atopic eczema (or atopic dermatitis).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Atopic eczema is a chronic inflammatory skin disease that affects 15-20% of children and 12% of adults and leads to significant loss of quality of life. It results from a complex interaction of genetic and environmental factors, and is characterised by dysregulation of the cutaneous immune system. Specifically, in the skin of eczema patients there is a persistence of T lymphocytes (a crucial cell involved in regulating the immune system), and an overproduction of certain cytokines (signalling molecules that are essential in producing inflammatory responses).

The study intends to investigate the causes of atopic eczema by examining the number, characteristics and function of T lymphocytes in the skin and the blood of eczema patients, as well as the types of cytokine they produce. To achieve this the investigators aim to take skin biopsies, tissue fluid (from induced skin suction blisters) and blood samples from adult eczema patients and healthy controls for analysis. Additionally, in these groups a cutaneous immune response will be initiated by injecting tuberculin protein purified derivative (the Mantoux test) into the skin, to further investigate how the behaviour of T lymphocytes varies between eczema patients and healthy controls.

This research is important in view of the high prevalence of atopic eczema in the population. An improved understanding of its causes will hopefully lead to more effective treatments for this condition in future.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of atopic dermatitis (according to United Kingdom Working Party's diagnostic criteria)
  • Previous Bacillus Calmette-Guerin vaccination

Exclusion Criteria:

  • Unable to give written informed consent
  • Previous history of hypersensitivity to local anaesthetic (for skin biopsy) or tuberculin PPD (for skin test)
  • Pregnancy or breast feeding
  • History of tuberculosis
  • Recent infection or immunisation (within last month)
  • Known immunodeficiency e.g. HIV infection, primary immunodeficiency, any history of chemotherapy or radiotherapy
  • Systemic steroids within the last month or any other immunosuppressive medications (eg. methotrexate, ciclosporin or azathioprine) within the previous 3 months
  • Phototherapy within the previous 28 days
  • Treatment with potent topical corticosteroids or tacrolimus ointment within the previous 7 days
  • Significant co-morbidity (diabetes, renal failure, liver failure, heart failure)
  • On warfarin or known bleeding disorder
  • History of neoplasm in last 10 years (not including basal cell carcinoma)
  • Previous keloid scarring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin biopsy
5mm skin punch biopsy on forearm
Procedure: Skin biopsy
Experimental: Skin suction blister
Skin suction blister induced on forearm
Procedure: Skin suction blister
Experimental: Mantoux, skin biopsy, suction blister
0.1ml tuberculin purified protein derivative (PPD) is injected intradermally into an area of non-lesional skin on the volar aspect of each of the patient's forearms. This is followed by a skin biopsy on one arm and induction of a skin suction blister on the other arm.
Procedure: Skin biopsy
Procedure: Skin suction blister
Biological: Mantoux test
Other Names:
  • Tuberculin PPD (SSI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers
Time Frame: Up to 14 days
Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Dermatrust

Investigators

  • Principal Investigator: Malcolm Rustin, MBBS MRCP MD, Royal Free London NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0410
  • 14/LO/0243 (Other Identifier: Health Research Authority)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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