RecruitingNAINTERVENTIONAL

Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis

This study is looking into a new device, ADHELASKIN, to help understand and measure how Systemic Sclerosis affects the skin. Systemic Sclerosis is a condition where the immune system mistakenly attacks healthy tissues, often leading to skin that becomes thick, hard, and less flexible. Currently, doctors often use their hands to feel the skin and score its thickness, but this method can vary from person to person. ADHELASKIN uses a special sensor to measure the skin's firmness, stiffness, and stretchiness more precisely. The main goal of this research is to see if this new device can accurately tell the difference between healthy skin and skin affected by Systemic Sclerosis. This could lead to a more reliable way to monitor the disease and develop better treatments in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

100

Start

07 May 2026

Estimated completion

01 May 2027

D013493

What is this study about?

Systemic Sclerosis is a long-term condition where the body's immune system attacks healthy tissues. This can lead to various problems, but often it causes the skin to become thick, hard, and lose its natural stretchiness. Doctors need ways to measure these skin changes accurately to understand how the disease is progressing and whether treatments are working. Currently, they might feel the skin by hand and give it a score, but this method can sometimes be inconsistent and doesn't always pick up small changes.

Because of these limitations, scientists are always looking for better, more objective tools. This is where the ADHELASKIN device comes in. It's a new technology that uses a tiny ruby ball to gently press on the skin and measure its stiffness, firmness, and how stretchy it is. Think of it like a very precise touch sensor. This study wants to find out if ADHELASKIN can clearly show the differences between skin from healthy people and skin from people with Systemic Sclerosis.

If ADHELASKIN proves to be accurate and reliable, it could become a valuable tool for doctors. It might help them track the disease more effectively, understand how treatments are affecting the skin, and ultimately improve care for people living with Systemic Sclerosis. This research is a step towards finding better ways to assess and manage this complex condition.

Key takeaways

The study tests a new device (ADHELASKIN) to measure skin changes in Systemic Sclerosis.
It aims for a more accurate and objective way to assess skin stiffness and thickness.
This could help doctors better track the disease and evaluate treatments.
Both people with Systemic Sclerosis and healthy individuals can join.
Participation involves non-invasive skin measurements and no new medications.
It's a chance to contribute to future medical understanding.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. The study is looking for two groups of people: individuals with Systemic Sclerosis and a control group of healthy people without any significant skin problems.

If you have Systemic Sclerosis, your diagnosis must meet specific medical guidelines from 2013 (known as ACR/EULAR criteria). If you don't have Systemic Sclerosis, you should not have any major skin conditions that cause inflammation or scarring.

There are also some important rules about who cannot participate. For example, if you are currently in prison, have been admitted to hospital without your consent, or are under a legal arrangement where someone else makes decisions for you (like guardianship), you cannot join. Also, if you have other inflammatory or scarring skin conditions that are not related to Systemic Sclerosis, you would not be able to participate.

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.

Are you at least 18 years old?
Do you have Systemic Sclerosis (or are you a healthy volunteer)?
Are you not currently in prison or under similar legal restrictions?
Have you not been told you cannot consent for yourself?
Do you not have other significant inflammatory or scarring skin conditions?

Answer every question to see your result.

What does participation involve?

The brief summary focuses on the device's assessment, so detailed participation steps are not provided. However, generally, taking part in a study like this would involve:

* **Initial Visit:** You would likely have a first appointment where the study is explained in full, you can ask questions, and if you agree, you would sign a consent form. During this visit, your medical history might be reviewed to ensure you meet the study criteria. * **Skin Assessment:** You would have your skin checked using the new ADHELASKIN device. This is a non-invasive test, meaning it doesn't break the skin and involves the device gently touching different areas, likely on your arms, legs, or torso depending on the study design. This assessment would be similar to feeling the skin but with a precise machine. * **Additional Assessments (Potential):** Depending on the study's detailed plan (which isn't fully in this summary), you might also have other standard skin checks or measurements done to compare with the ADHELASKIN results. This could include a doctor feeling your skin (the mRSS). * **Number of Visits:** The summary doesn't specify how many visits are needed, but for an assessment tool study, it might involve one or two visits for measurements. There is no mention of taking any medication as part of this study. * **Total Duration:** The total time commitment isn't stated, but if it's an assessment study, it could range from a single visit lasting a few hours to a few visits over a short period.

Potential risks and benefits

Taking part in a research study has both potential benefits and risks. For you, a potential benefit could be contributing to scientific understanding that might lead to better diagnostic tools and treatments for Systemic Sclerosis in the future. There is no direct personal medical benefit expected from the ADHELASKIN device during the study itself, as it is purely for measurement. The risks associated with using the ADHELASKIN device are expected to be very low, as it's a non-invasive tool that gently touches the skin. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Saint-Etienne
Approximate
Saint-Priest-en-Jarez, France· Recruiting

Common questions

What is Systemic Sclerosis?

It's a condition where your body's immune system mistakenly attacks healthy tissues, often causing skin to become thick and hard.

What is the ADHELASKIN device?

It's a new tool that uses a special sensor to measure the firmness, stiffness, and stretchiness of your skin very precisely.

Will I have to take new medication if I join this study?

No, this study is about assessing a device, not testing new medication. You would continue your usual treatments.

What does a 'non-invasive' test mean?

It means the test doesn't involve needles, cuts, or anything that breaks the skin. It just involves the device touching your skin.

How long will I be in the study if I participate?

The summary doesn't specify length, but studies using assessment devices often involve one or a few visits over a short period. Your doctor can give more details.

How to find out more

Lucile GRANGE, MD

lucile.grange@chu-st-etienne.fr (0)4 77 82 83 42 Official trial record

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