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PGE2/IL-22 Pathway in Various Forms of Eczema

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ClinicalTrials.gov Identifier: NCT04133506
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

Brief Summary:

Objectives: Eczema is a chronic inflammatory skin condition characterised immunologically by T cellmediated inflammation. The pathogenic mechanisms involved in its development are incompletely understood and targeted treatment options are limited. The investigators will study the Prostaglandin E2 (PGE2)/IL22/IL17 pathway which plays an important role in murine model chronic skin inflammation. The investigators wish to identify subtypes of human eczema in which this pathway may be involved and to determine whether manipulation of this pathway may offer effective new treatments.

Design, tissue/cells, techniques and measurements: To address these objectives, the investigators will measure the expression of IL22, IL17A and PGE2 synthases and receptors in skin biopsies from eczema and psoriasis patients using immunohistochemistry (confirming this with RT-PCR). IL22/IL17 producing Tcells (from peripheral blood) and their skin-homing capability (by ex-vivo cell culture and flow cytometry) will be measured. Deriving immune cells from skin biopsies using Villanova's technique1, the investigators will determine the T-cell response to PGE2 looking at PGE2 receptors and cytokine expression, interrogating these cells by flow cytometry. To determine the sequence and kinetics of activation of the PGE2/IL22/IL17 pathway the investigators will measure each immune mediator at specific time points by recruiting healthy volunteers inducing irritant and allergic contact dermatitis using dithranol and DNCB respectively. The investigators will repeat the experiment dividing volunteers into two arms, one pre-treated for one week with a non-specific prostaglandin inhibitor (aspirin) and the second with a placebo control.


Condition or disease Intervention/treatment
Eczema Drug: Aspirin 300mg

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Defining a PGE2 Pathway in Regulating Eczema
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
acute eczema
acute eczema patients with eczema <72 hours no drugs
chronic eczema
chronic eczema with eczema > 72 hours no drugs
allergic contact dermatitis
allergic contact dermatitis with a clear allergen identified no drugs
psoriasis patients
patients with plaque psoriasis no drugs
healthy volunteers
dithranol or DNCB (used to induce irritant or allergic eczema used safely in similar research studies for decades) aspirin to half the group to assess the effects on downstream mediators
Drug: Aspirin 300mg
see earlier (only half of healthy volunteers receive aspirin)




Primary Outcome Measures :
  1. Laboratory assessment of skin and blood of patients [ Time Frame: 3 years ]
    We wish to determine if PGE2 and IL22 levels in skin and blood are elevated in specific subtypes of eczema by measuring this in their skin and blood when not receiving any treatments. This will take the form of measuring protein levels of PGE2 and IL-22 in blood and skin. This will allow us to stratify patients according to those in whom PGE2 and IL-22 is over-expressed (we don't expect this to be elevated in all patients) and will enable us to determine who we could treat in clinical trial in the future with future therapies.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The investigators will require 12 from each of the three eczema groups: acute, chronic and Allergic Contact Dermatitis as well as 4 psoriasis patients and 4 samples from plastic surgery patients. This comes to a total of 44 patients.

For healthy controls undertaking the dithranol/DNCB study the investigators will anticipate a group of 8 and when the investigators repeat the experiment and administer aspirin the investigators will divide these 8 patients into 4 who receive aspirin (a non-selective prostaglandin inhibitor) and 4 who do not receive aspirin.

44 patients (including the banked healthy skin of plastic surgery patients) +8 healthy volunteers= 52 as above.

Criteria

Inclusion Criteria:

-

Eczema patients must meet criteria of one of the following groups:

Have eczema and attend the Edinburgh Dermatology Clinic.

The normal control patients will be matched for age and sex as closely as possible to our eczema patients.

The participants should be able to give informed consent and should be at least 16 years of age with no upper limit.

Psoriasis patients:

The participants will have a diagnosis of psoriasis and attend Edinburgh Dermatology clinic.

Controls will be age and gender matched. There is no upper age limit, but the lower age limit is 16.

Healthy volunteers:

The participants should have no intolerance or allergy to aspirin and no allergy/sensitivity to dithranol or DNCB.

There is no upper age limit but the lower age limit is 16.

Exclusion Criteria:

-

Eczema patients:

  1. Treatment with systemic corticosteroids or other immune response modifying systemic drugs such as azathioprine or methotrexate 2 months before the study starts.
  2. Inability to give informed consent.

Psoriasis:

  1. Treatment with systemic corticosteroids or other immune response modifying systemic drugs such as azathioprine or methotrexate 2 months before the study starts.
  2. Inability to give informed consent.

For healthy volunteers:

  1. intolerance/allergy to aspirin and allergy/sensitivity to dithranol or DNCB.
  2. involvement in another study at the same time.
  3. pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133506


Contacts
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Contact: Fiona Cunningham, MB BCh 0131 242 6593 ext 01315363229 fiona.cunningham@ed.ac.uk
Contact: Richard Weller, MB BCh 0131 536 3229 ext 01315363229

Sponsors and Collaborators
NHS Lothian
Investigators
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Principal Investigator: Richard Weller, MB BCh NHS and University of Edinburgh

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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT04133506     History of Changes
Other Study ID Numbers: 19/SS/0094
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: only if ethically permissible and unquestionably relevant to the eczema community and for patient benefit

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics