Atopic DermatitisNCT02102841
Investigating Immune Mechanisms in Atopic Eczema
A study testing Skin biopsy, Skin suction blister and Mantoux test in people with Atopic Dermatitis, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the mechanisms behind the immune dysfunction that occurs in atopic eczema (or atopic dermatitis). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Skin biopsy, Skin suction blister and Mantoux test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of atopic dermatitis (according to United Kingdom Working Party's diagnostic criteria)
- Previous Bacillus Calmette-Guerin vaccination
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free London NHS Foundation Trust
London, NW3 2QG
About this study
Official title: 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).
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Skin biopsy, Skin suction blister, Mantoux test
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
Skin suction blisterProcedure or surgery
Mantoux testBiological
Also called Tuberculin PPD (SSI)
| Study group | Role | What they receive |
|---|---|---|
| Skin biopsy | Experimental | 5mm skin punch biopsy on forearm Receives: Procedure: Skin biopsy |
| Skin suction blister | Experimental | Skin suction blister induced on forearm Receives: 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. Receives: Procedure: Skin biopsy; Procedure: Skin suction blister; Biological: Mantoux test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Recruitment no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatrust
- Responsible party
- Sponsor
- Investigators
- Malcolm Rustin, MBBS MRCP MD, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102841
- Sponsor's protocol ID
- 13/0410
- Other IDs
- 14/LO/0243
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2014
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7918015
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Skin Resident T Cells in Atopic Eczema and Responses to Antigen Challenge
- ClinicalTrials.gov ID
- NCT02102841
- Acronym / sponsor ID
- 13/0410
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment no longer feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Dermatrust
- Study start
- May 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the mechanisms behind the immune dysfunction that occurs in atopic eczema (or atopic dermatitis).
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skin biopsy | Experimental | Procedure: Skin biopsy5mm skin punch biopsy on forearm |
| Skin suction blister | Experimental | Procedure: Skin suction blisterSkin suction blister induced on forearm |
| Mantoux, skin biopsy, suction blister | Experimental | Procedure: Skin biopsy, Procedure: Skin suction blister, Biological: Mantoux test0.1ml 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of atopic dermatitis (according to United Kingdom Working Party's diagnostic criteria)
- Previous Bacillus Calmette-Guerin vaccination
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsy | Procedure or surgery | Mantoux, skin biopsy, suction blister, Skin biopsy |
| Skin suction blister | Procedure or surgery | Mantoux, skin biopsy, suction blister, Skin suction blister |
| Mantoux testAlso: Tuberculin PPD (SSI) | Biological | Mantoux, skin biopsy, suction blister |
Primary outcome
Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers
Time frame: Up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 7918015Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Rustin, MBBS MRCP MD principal investigator
Royal Free London NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy, Skin suction blister and Mantoux test in people with Atopic Dermatitis, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of regulatory T cells in lesional skin of atopic dermatitis patients compared to healthy volunteers (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.