This trial is active, not recruiting.

Condition atopic dermatitis
Treatments skin biopsy, skin suction blister, mantoux test
Sponsor University College, London
Collaborator Dermatrust
Start date May 2014
End date May 2017
Trial size 140 participants
Trial identifier NCT02102841, 13/0410, 14/LO/0243


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
5mm skin punch biopsy on forearm
skin biopsy
Skin suction blister induced on forearm
skin 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.
skin biopsy
skin suction blister
mantoux test Tuberculin PPD (SSI)

Primary Outcomes

Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers
time frame: Up to 14 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Investigating the Role of Skin Resident T Cells in Atopic Eczema and Responses to Antigen Challenge
Principal investigator Malcolm Rustin, MBBS MRCP MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University College, London.