Understanding skin health in systemic sclerosis

DERMATOMICS: Identifying Regulators of Skin Homeostasis

This study looks at how systemic sclerosis affects skin health by comparing skin samples and blood from people with the condition to those without it.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Relation Therapeutics (industry)
• Drugs / interventions: Car-T
• Locations: 2 sites (Leeds and 1 other locations)
• Trial ID: NCT06894654 on ClinicalTrials.gov

What this trial studies

The DERMATOMICS study aims to explore the biology of systemic sclerosis (SSc), a rare autoimmune condition that affects the skin and internal organs. By conducting skin punch biopsies, blood sampling, and questionnaires, the study seeks to identify the underlying mechanisms that contribute to skin manifestations in SSc. This observational study will involve both participants diagnosed with SSc and healthy individuals for comparison, providing insights into the disease's impact on skin integrity and overall quality of life.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of systemic sclerosis.

Not a fit: Patients with underlying malignancies, skin cancer, or those currently on immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of systemic sclerosis, enhancing patient care and quality of life.

How similar studies have performed: While there have been studies on systemic sclerosis, this specific approach focusing on skin homeostasis is relatively novel.

Eligibility criteria

Inclusion Criteria:

SSc participant cohort:

1. Age of 18 years inclusive, or older at the time of signing the informed consent
2. Documented diagnosis of systemic scleroderma (SSc) (early or late diagnosis)

Healthy cohort:

1. Approximate age/sex matching (majority of healthy participants to be recruited after cohort 1 and 2)
2. Absence of Raynaud's Phenomenon
3. Absence of lung disease
4. Not on immunosuppressive treatment

Exclusion Criteria:

SSc participant cohort:

1. Participants unable to provide informed consent.
2. Participants with suspected/established underlying malignancy.
3. Participants with suspected/established skin cancer.
4. Participants with suspected/established bloodborne disease.
5. Current enrolment or past participation in a study involving an investigational drug within 3 months or 5 half-lives of the investigational drug treatment (whichever is longer) before the day of sample collection.
6. Participants treated with cellular therapies, e.g., HSCT, Car-T cells, T cell engagers.
7. Participants treated with B-cell depletion therapies within 6 months.
8. Concurrent diagnosis of any other connective tissue disease (CTD) in overlap.
9. Diagnosis of other non-SSc dermatological conditions.
10. Systemic sclerosis-like illness, including but not limited to localised scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \[nephrogenic systemic fibrosis\], or due to metabolic disease).
11. History or presence of significant non-sclereoderma related cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological disorders, or treatments for those, capable of significantly interfering with the results and interpretation of data.
12. Smoking history (5 years smoke free acceptable)

Where this trial is running

Leeds and 1 other locations

• Chapel Allerton Hospital — Leeds, United Kingdom (NOT_YET_RECRUITING)
• Royal Free Hospital — London, United Kingdom (RECRUITING)

Conditions: Systemic Sclerosis, Scleroderma, Skin, systemic sclerosis, SSc