NCT07771673

Brief Summary

The goal of this observational study is to identify the immune profile underlying various inflammatory skin diseases, through multi-omic procedures. The main questions it aims to answer are:

  1. 1.What are the molecular and immune signatures of individuals with inflammatory skin disease?
  2. 2.Can these signatures reveal potential therapeutic targets for individuals with inflammatory skin disease?
  3. 3.How do patients' multi-omic signatures change before and after receiving systemic therapy?
  4. 4.Can the samples and data collected through this study provide a valuable bioresource for future skin disease research?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jul 2031

First Submitted

Initial submission to the registry

August 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4.8 years

First QC Date

August 10, 2026

Last Update Submit

August 13, 2026

Conditions

Inflammatory Skin Conditions

Keywords

Inflammatory skin diseaseEpidermoylsis BullosaNanoStringMultiomicsEczemaPsoriasis

Outcome Measures

Primary Outcomes (1)

  • DLQI

    Dermatology Quality of Life Index

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

Secondary Outcomes (12)

  • EBDASI

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

  • iscorEB

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

  • LIS

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

  • QOLEB

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

  • WI-NRS

    Baseline and Day 3, Week 1, Week 16, Month 6, Month 12

  • +7 more secondary outcomes

Study Arms (2)

Healthy participants who do not have an inflammatory skin condition

Participants with an inflammatory skin condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dermatology clinics (Guys and St Thomas' Hospital and University Hospitals Birmingham) and community (healthy volunteers)

You may qualify if:

  • Able to provide written informed consent prior to performing any protocol-related procedures, including screening.
  • Adults (≥18 years) with confirmed diagnosis of inflammatory skin disease (defined as any skin disease with an inflammatory component, including but not limited to, genetic skin disease, such as EB), OR
  • Adults age (≥18 years) without skin or systemic disease.

You may not qualify if:

  • Inability to give written informed consent.
  • Participants who have received topical corticosteroids to sites of biopsies (inflamed area of skin) for at least 2 weeks prior to tissue sampling.
  • Inability to participate in study-specific procedures.
  • Participants who are pregnant (confirmed on a positive urine pregnancy test) or breastfeeding
  • Enrolment in any interventional study with systemic treatment within 3 months prior to baseline biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Pseudonymised research blood samples and their derivatives will be retained, including DNA, RNA, serum, plasma and peripheral blood mononuclear cells. Skin biopsy tissue will also be retained. Subject to participant consent and clinical relevance, optional retained samples may include skin and mucosal swabs, mucosal and scalp biopsy tissue, stool, saliva and skin that would otherwise be discarded during surgery.

MeSH Terms

Conditions

DermatitisEczemaPsoriasis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, Papulosquamous

Study Officials

  • Su M Lwin, MRCP (Derm) PhD BSc (Hons)

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+44 20 7188 7188kate.1.widdows@kcl.ac.uk

Clinical Trial Manager

CONTACT

+44 20 7188 7188rashida.pramanik@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 18, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

August 18, 2026

Record last verified: 2026-08