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DERMATOMICS: Identifying Regulators of Skin Homeostasis

The DERMATOMICS study is looking into severe skin conditions, particularly Systemic Sclerosis (SSc), also known as scleroderma. These conditions affect skin, body organs, and overall well-being. Current treatments often only manage symptoms and can have side effects. Researchers want to understand the root causes of SSc by studying skin and blood samples to identify new targets for more effective and personalised treatments. They will examine how genetics, environment, and body cells interact to cause the disease, hoping to improve care for people with SSc and similar conditions, especially focusing on finding better ways to address skin and lung problems.

At a glance

Status
Recruiting
Sponsor
Relation Therapeutics
Enrolment target
500
Start
10 Dec 2024
Estimated completion
01 Nov 2030
Systemic Sclerosis (SSc)

What is this study about?

This study, called DERMATOMICS, is all about understanding severe skin conditions that are driven by the immune system, such as scleroderma (Systemic Sclerosis, or SSc). These conditions don't just affect the skin; they can also impact other organs and significantly reduce a person's quality of life, often causing discomfort and disfigurement. While there are treatments available, they often focus on managing symptoms and don't always get to the heart of the problem, and they can sometimes have unwanted side effects. We urgently need new and better ways to treat these conditions.

The DERMATOMICS study will focus specifically on Systemic Sclerosis (SSc). SSc is a complex disease where the body's immune system mistakenly attacks its own tissues, leading to scarring (fibrosis) in the skin and internal organs. This scarring can be very serious, especially when it affects the lungs, leading to breathing difficulties and other complications. By studying samples from people with SSc, researchers hope to uncover the exact ways that cells, genes (our DNA), and the environment all work together to cause the disease.

The main goal is to find new and more effective treatment approaches. Researchers will look closely at what makes SSc severe in some people and less so in others. By understanding these differences at a very detailed level, they aim to discover new targets for medicines that could lead to more personalised and successful treatments for SSc and other similar immune-driven conditions affecting the skin and lungs. This could eventually lead to better lives for many people.

Key takeaways

  • This study aims to understand severe skin conditions like scleroderma (SSc).
  • It involves providing skin and blood samples, and answering a questionnaire.
  • The goal is to find new ways to treat SSc by understanding its causes.
  • Participation will not involve receiving any new treatment or medication.
  • Your contribution could help develop future, more effective treatments.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be part of this important study, you would need to be at least 18 years old. If you have been diagnosed with Systemic Sclerosis (SSc), either recently or a while ago, you might be able to participate. The study is also looking for healthy volunteers who can help by providing comparisons; these volunteers should be around the same age and sex as the SSc participants.

There are some reasons why you might not be able to join. For example, if you have certain other serious health conditions like cancer or other specific connective tissue diseases that overlap with SSc, have had certain types of cell or immune-suppressing therapies recently, or are currently taking part in another drug study. Healthy volunteers specifically should not have a condition called Raynaud's Phenomenon, any lung disease, or be taking medicines that suppress the immune system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am 18 years old or older.
  2. I have been diagnosed with Systemic Sclerosis (SSc).
  3. I do not have a current cancer diagnosis.
  4. I haven't taken part in another drug study in the last 3 months.
  5. I have not recently received certain types of advanced cell therapies.
Answer every question to see your result.

What does participation involve?

If you decide to take part in the DERMATOMICS study, it will involve a few steps. You will be asked to complete a questionnaire about your health. The most involved part of the study includes providing a small skin sample (this is called a skin punch biopsy) and a blood sample. These samples are crucial for helping researchers understand the condition at a very detailed level. There are no study medications involved, and this is not a treatment trial. The total duration of your participation would involve the process of providing these samples, and any follow-up would be to ensure your well-being after the biopsy. You would not need repeated visits over a long period.

Potential risks and benefits

Participating in this study has potential benefits. While it won't directly treat your condition, your contribution will be vital in helping researchers understand Systemic Sclerosis better and could lead to new, more effective treatments for others in the future. As with any medical procedure, there are some minor risks, mainly associated with the skin biopsy, such as slight discomfort, bruising, or a small chance of infection at the biopsy site. Blood sampling also carries a small risk of bruising. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Chapel Allerton Hospital
    Verified postcode
    Leeds, United Kingdom· Not yet recruiting
  • Royal Free Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is Systemic Sclerosis (SSc)?

Systemic Sclerosis, or scleroderma, is a chronic condition where the body's immune system mistakenly attacks its own tissues, causing scarring (fibrosis) in the skin and sometimes internal organs.

What is a skin punch biopsy?

A skin punch biopsy is a minor medical procedure where a small, cylindrical piece of skin is removed, usually after numbing the area. It helps doctors examine the skin more closely.

Will I receive treatment as part of this study?

No, this is a research study to understand the disease better, not a treatment trial. You will not receive any medication or treatment as part of your participation.

How long will I need to be involved in the study?

Your participation typically involves a single visit to provide samples and complete a questionnaire. There is no long-term follow-up or repeated visits required for this specific study.

What will happen to my samples?

Your skin and blood samples will be used for detailed laboratory analysis, including genetic and molecular studies, to help researchers understand the causes and progression of Systemic Sclerosis.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "DERMATOMICS: Identifying Regulators of Skin Homeostasis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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