PGE2/IL-22 Pathway in Various Forms of Eczema

NCT04133506 | Completed

• 1 other identifier: 19/SS/0094
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Outcome Measures

Primary Outcomes (1)

• Laboratory assessment of skin and blood of patients

  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.

  3 years

Study Arms (5)

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

Interventions

Aspirin 300mg DRUG

see earlier (only half of healthy volunteers receive aspirin)

healthy volunteers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Eczema patients:
• Treatment with systemic corticosteroids or other immune response modifying systemic drugs such as azathioprine or methotrexate 2 months before the study starts.
• Inability to give informed consent.
• Psoriasis:
• Treatment with systemic corticosteroids or other immune response modifying systemic drugs such as azathioprine or methotrexate 2 months before the study starts.
• Inability to give informed consent.
• For healthy volunteers:
• intolerance/allergy to aspirin and allergy/sensitivity to dithranol or DNCB.
• involvement in another study at the same time.
• pregnancy

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

QMRI

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Eczema

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Richard Weller, MB BCh

  NHS and University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: November 4, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

GB (1)