💬In plain words
What the trial is, and whether it could suit you
Diseases of the skin associated with chronic immune driven conditions, including scleroderma, lupus, dermatomyositis, psoriasis, and atopic dermatitis, significantly impact skin integrity, function, and overall quality of life. These conditions can lead to severe disfigurement, discomfort, and systemic complications, necessitating long-term medical intervention. The prevalence of these skin disorders is rising globally, driven by genetic, environmental, and immunological factors. Unravelling the mechanisms leading to skin manifestations may shed further insights in the overall mechanisms of disease.
The DERMATOMICS study will focus on understanding systemic sclerosis (SSc) biology.
Systemic Sclerosis (SSc) is a highly heterogeneous rare autoimmune fibrotic condition affecting the skin and internal organs. SSc is classified as a Connective Tissue Disease (CTD), a family of conditions in
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
HealthTeky