Multi-Omic SignAtures of Inflammatory Cutaneous Diseases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Healthy participants who do not have an inflammatory skin condition
Group B: Participants with an inflammatory skin condition

Trial outcomes

Primary outcomes

1

DLQI

Dermatology Quality of Life Index

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

Secondary outcomes

1

EBDASI

Epidermolysis Bullosa Disease Activity and Scarring Index

Time frame
Baseline and Day 3, Week 1, Week 16, Month 6, Month 12
2

iscorEB

Instrument for Scoring Clinical Outcomes of Research for Epidermolysis Bullosa

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

LIS

Leuven Itch Scale

Time frame
Baseline and Day 3, Week 1, Week 16, Month 6, Month 12
4

QOLEB

Quality of Life Evaluation in Epidermolysis Bullosa

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

LifeArc

Collaborator

DEBRA

Collaborator

This trial is not recruiting at the moment. You can still explore other options: