The Role Of Neutrophil Proteases As Global Regulators Of Il-1 Family Cytokine Activity In Skin Disorders

NCT04750161 | Unknown DMC

• 1 other identifier: CRFSJ0133
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pro-inflammatory cytokines are critically important drivers of inflammatory and autoimmune diseases and cytokine-targeted biologics have been transformative in the treatment of several inflammatory and autoimmune diseases. As the diversity of approved cytokine-targeted biologic therapies grows, it will become increasingly important to stratify patients on the basis of specific genetic or disease biomarker phenotypes to ensure that patients receive the appropriate cytokine-targeted biologic, at the appropriate dose, and at the appropriate time. This project aims to explore patterns of pro-inflammatory cytokine/chemokine expression within normal versus (i) psoriatic, (ii) eczematic, (iii) ichthyotic human skin, as well as in human and mouse models of skin inflammation, with the objective of identifying cytokine response profiles ('cytokine fingerprints') that will provide a molecular basis for (a) the stratification of patients into disease subtypes that (b) enable cytokine-directed biologics to be targeted towards patients that are most likely to benefit from them. The investigators anticipate that 'cytokine fingerprinting' will aid in the selection of the most appropriate biologics in patients that are most likely to benefit from such therapies.

Conditions

Psoriasis Vulgaris; Atopic Dermatitis; Ichthyosis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Cytokine Profiles

  The generation of a large dataset of cytokine profiles from uninvolved versus involved areas of skin from approximately 80 patients displaying heterogenous clinical symptoms.

  6 months

Secondary Outcomes (1)

• Develop sampling techniques

  6 months

Study Arms (4)

Psoriasis Vulgaris

Other: No intervention

Atopic Dermatitis

Other: No intervention

Ichthyosis Vulgaris

Other: No intervention

Healthy Controls

Other: No intervention

Interventions

No intervention OTHER

No intervention will be given to participants. It is purely observational.

Atopic Dermatitis; Healthy Controls; Ichthyosis Vulgaris; Psoriasis Vulgaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A mix of participants from all ages and genders, 20 from each inflammatory skin disorders: psoriasis, atopic dermatitis and ichthyosis vulgaris as well as 20 healthy controls.

You may qualify if:

• Have psoriasis, atopic Dermatitis or ichthyosis vulgaris with visible skin lesions, preferably on the forearm which are amenable to sampling.
• Healthy control group without any skin disease.

You may not qualify if:

• Under 18 years old
• Fully treated skin disease without active lesions

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead
• Science Foundation Ireland: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Clinical Research Facility, St James Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Ichthyosis Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Keratosis

Study Officials

• Alan Irvine

  St. James Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Coalter, MB BCh BAO MSc

CONTACT

0858351212; coalterm@tcd.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 11, 2021
• Study Start: March 2, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

IE (1)