Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2014-05-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis
NCT02369432
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
NCT02087943
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
NCT00310492
Evaluation of the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
NCT02144142
Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis
NCT07054736
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Skin biopsy
5mm skin punch biopsy on forearm
Skin biopsy
Skin suction blister
Skin suction blister induced on forearm
Skin suction blister
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.
Skin biopsy
Skin suction blister
Mantoux test
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Skin biopsy
Skin suction blister
Mantoux test
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Previous Bacillus Calmette-Guerin vaccination
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dermatrust
UNKNOWN
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Malcolm Rustin, MBBS MRCP MD
Role: PRINCIPAL_INVESTIGATOR
Royal Free London NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14/LO/0243
Identifier Type: OTHER
Identifier Source: secondary_id
13/0410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.