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临床试验/NCT02102841
NCT02102841撤回不适用

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

University College, London1 个研究点 分布在 1 个国家开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Skin biopsy

Experimental

5mm skin punch biopsy on forearm

干预措施: Skin biopsy (Procedure)

Skin suction blister

Experimental

Skin suction blister induced on forearm

干预措施: Skin suction blister (Procedure)

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.

干预措施: Skin biopsy (Procedure)

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.

干预措施: Skin suction blister (Procedure)

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.

干预措施: Mantoux test (Biological)

结局指标

主要结局

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

时间窗: Up to 14 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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