RecruitingPHASE2INTERVENTIONAL

Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

This research study is investigating a new treatment for hard lumps that can form under the skin or in soft tissues in people with certain conditions, such as Systemic Sclerosis, Dermatomyositis, and a rare bone disorder called iPPSD2. These lumps, often made of calcium or bone-like material, can cause pain and make daily activities difficult. Currently, there aren't many effective medicines for them, and surgery is often the only option when they become problematic. The study is testing a medicine called Sodium Thiosulfate (STS), which has shown promise in earlier research for similar problems. In this study, STS will be given directly into the lumps as an injection. The main goal is to see how well STS works to reduce these lumps and if it's safe for patients. It's a 'Phase II' study, which means it's still in the earlier stages of testing, but the hope is to find a better treatment option for these challenging conditions.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Limoges

Enrolment target

Start

06 Jan 2020

Estimated completion

06 Jun 2027

Systemic Sclerosis Dermatomyositis iPPSD2

What is this study about?

You might have a condition like Systemic Sclerosis, Dermatomyositis, or iPPSD2, which can sometimes cause hard lumps to form under your skin or in other soft parts of your body. These lumps are often made of calcium or bone-like material, and doctors call them 'calcifications' or 'ossifications'. They can be painful, make it hard to move, and generally affect your quality of life. Right now, there aren't many good medical treatments available for these lumps, and sometimes surgery is the only way to deal with them if they get too big or cause too many problems.

Researchers are looking for new and better ways to treat these lumps. This study is focusing on a medicine called Sodium Thiosulfate, or STS for short. STS is already used for other medical reasons, but some early research has suggested it might also help with these hard lumps. Our doctors have been working with STS and have seen some promising results when it's given directly into the lumps. This study aims to properly test if STS injections are effective and safe for treating these specific types of lumps.

This is a 'Phase II' study, which means it's an important step in researching new treatments. The main goal is to see if injecting STS directly into your lumps can make them smaller or less problematic, and to check for any side effects. If this study shows good results, it could pave the way for STS to become a widely available treatment, offering a much-needed option for people struggling with these challenging lumps.

Key takeaways

This study is testing a new way to treat troublesome hard lumps under the skin.
The lumps are linked to conditions like Systemic Sclerosis, Dermatomyositis, or iPPSD2.
The treatment involves injections of a medicine called Sodium Thiosulfate (STS) directly into the lumps.
The main goals are to see if STS is effective and safe.
This is a 'Phase II' study, meaning it's an important research step for a potential new treatment.

Who may be eligible?

To be considered for this study, you would need to have specific types of hard lumps (calcifications or ossifications) caused by Systemic Sclerosis, Dermatomyositis, or iPPSD2. You must be at least 2 years old, and a team of specialists would need to agree that the lumps are significantly affecting your health or daily activities, and that this treatment makes sense for you. Also, you shouldn't have any plans for surgery on these lumps within the next year.

There are also some reasons why you might not be able to join. For example, if you are allergic to STS or any of its ingredients, or if you are pregnant, breastfeeding, or taking certain blood-thinning medications, you wouldn't be able to participate. You also need to be able to safely receive injections locally into the lump. If you are a woman who could become pregnant, you'd need to use effective contraception, and men with partners who could become pregnant would also need to use condoms during the study.

Ultimately, you and your parents (if you are a child) would need to fully understand the study and agree to take part by signing a consent form. Everyone involved in the study must also be part of the social security 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.

Do I have hard lumps caused by Systemic Sclerosis, Dermatomyositis, or iPPSD2?
Am I at least 2 years old?
Am I NOT allergic to Sodium Thiosulfate (STS)?
Am I NOT pregnant or breastfeeding, and not taking certain blood thinners?
Do I have no plans for surgery on these lumps in the next 12 months?
Am I willing and able to use contraception (if applicable) during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, the main part of the treatment involves receiving injections of the study medicine, Sodium Thiosulfate (STS), directly into your hard lumps. The exact number of visits and the full treatment schedule will be explained by the study team, as it can vary, but these injections would be given over a period of time. You would have regular check-ups to see how the lumps are responding and to monitor your overall health.

Before you start, and during the study, you'll have various assessments, which might include scans, blood tests, and physical examinations to track your condition and the effects of the treatment. The study team will provide detailed information about all appointments, what each visit involves, and the total length of your participation, including follow-up checks after your last injection.

Potential risks and benefits

Participating in this study might offer a potential benefit by reducing the size or impact of your hard lumps, which could lessen pain and improve your ability to do daily activities. However, it's also important to remember that this is a research study, and there's no guarantee that the treatment will work for everyone. As with any medication or injection, there could be risks. You might experience side effects from the STS, or discomfort, bruising, or a reaction at the injection site. The study team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

CHU de BORDEAUX
Verified postcode
Bordeaux, France· Recruiting
Hospice Civil de Lyon
Verified postcode
Bron, France· Not yet recruiting
ApHp - Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
CHU de Limoges
Verified postcode
Limoges, France· Recruiting
ApHp - hôpital Lariboisière
Verified postcode
Paris, France· Recruiting
Hôpital de la Pitié Salpétriêre
Verified postcode
Paris, France· Not yet recruiting
CHU de ROUEN
Verified postcode
Rouen, France· Not yet recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What are 'calcifications' or 'ossifications'?

These are hard lumps that can form under your skin or in soft tissues. They're often made of calcium or bone-like material and can be painful or interfere with everyday activities.

What is Sodium Thiosulfate (STS)?

STS is a medicine that's already used for other health problems. Researchers are now looking into whether it can help treat these hard lumps.

How will STS be given in this study?

If you join the study, STS will be given directly into your hard lumps as an injection.

Is this a new treatment?

STS is an existing medicine, but its use for treating these specific hard lumps is new and is still being researched in this study.

Will I have to have surgery if I join this study?

No, if you join this study, you should not have any plans for surgery on these specific lumps within the next year. The study is an alternative to surgery.

How to find out more

Vincent GUIGONIS, MD

vincent.guigonis@unilim.fr 555056358 Official trial record

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