NCT02102841

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

March 31, 2014

Last Update Submit

April 27, 2021

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers

    Up to 14 days

Study Arms (3)

Skin biopsy

EXPERIMENTAL

5mm skin punch biopsy on forearm

Procedure: Skin biopsy

Skin suction blister

EXPERIMENTAL

Skin suction blister induced on forearm

Procedure: Skin suction blister

Mantoux, skin biopsy, suction blister

EXPERIMENTAL

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 biopsyProcedure: Skin suction blisterBiological: Mantoux test

Interventions

Skin biopsyPROCEDURE
Mantoux, skin biopsy, suction blisterSkin biopsy
Skin suction blisterPROCEDURE
Mantoux, skin biopsy, suction blisterSkin suction blister
Mantoux testBIOLOGICAL
Also known as: Tuberculin PPD (SSI)
Mantoux, skin biopsy, suction blister

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

  • Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, Bingham EA, Finlay AY, Pembroke AC, Graham-Brown RA, et al. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994 Sep;131(3):383-96. doi: 10.1111/j.1365-2133.1994.tb08530.x.

    PMID: 7918015BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Malcolm Rustin, MBBS MRCP MD

    Royal Free London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

GB(1)