RecruitingPHASE2INTERVENTIONAL

Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis

This study is looking into a new treatment called TOP-N53 for open sores on the fingertips, known as digital ulcers. These ulcers can affect people with a condition called systemic sclerosis, which causes skin hardening and other health issues. Researchers want to find out if TOP-N53 is safe when applied to these wounds and if it can help them heal. They'll also check if it reduces symptoms like pain, itching, redness, and bruising. The study includes men and women aged 18 to 69. Participants might also be taking another medicine called Sildenafil. The study compares TOP-N53 to a dummy treatment (placebo) to see how well it works and if it causes any problems.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Topadur Pharma AG

Enrolment target

Start

04 Feb 2025

Estimated completion

31 Mar 2026

Digital Ulcers in Systemic Sclerosis

What is this study about?

Imagine you have a cut or sore, and doctors are trying to find a better way to help it heal. This study is similar, but it focuses on a specific type of open sore called a 'digital ulcer' that appears on the fingertips. These ulcers can be quite painful and don’t heal easily for people who have a condition called systemic sclerosis. Systemic sclerosis is a rare illness that can make your skin hard and tight, and sometimes affects internal organs and blood vessels.

The main goal of this study is to test a new medicine in a gel form, called TOP-N53. Researchers want to see two main things: Firstly, is it safe to put TOP-N53 directly onto these fingertip ulcers? They'll be watching very carefully for any unwanted side effects. Secondly, they want to know if TOP-N53 can help with specific problems these ulcers cause, such as improving blood flow to the area, reducing pain, itching, redness, or any bruising or bleeding.

To figure this out, some people in the study will get TOP-N53, while others will receive a 'placebo' – that's a look-alike gel that doesn't contain any active medicine. This helps doctors see if any improvements are truly due to TOP-N53 or just from the body healing naturally or from the attention received. They will use different strengths of TOP-N53, but only introduce higher strengths if the lower ones are proven safe first. This careful approach helps ensure everyone's safety.

Key takeaways

This study is testing a new gel (TOP-N53) for fingertip ulcers caused by systemic sclerosis.
It aims to see if TOP-N53 is safe and helps with healing, pain, itching, and redness.
Some participants will receive the active gel, others a dummy gel (placebo).
You'll attend up to 8 visits over about a month, some possibly by phone.
You'll keep a diary to record your symptoms and how you're feeling.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be able to understand what's involved and give your agreement to take part. You also need to be an adult, aged between 18 and 69 years old, and have been diagnosed with systemic sclerosis.

You must have at least one active fingertip ulcer that's at least 3mm wide and affects your skin, not just the surface. You'll also need to meet certain requirements regarding other medications. For example, you might already be taking a specific blood pressure medicine called sildenafil regularly, or you might not be taking any similar medicines before the study starts. Other regular medications you take should have been at a steady dose for at least two weeks before joining.

If you're a woman who could become pregnant, you'll need to agree to use effective birth control throughout the study and for 7 weeks after your last treatment. Men with partners who could become pregnant also need to use appropriate birth control. The doctors will do a check-up to make sure you're generally healthy enough for the study, apart from your systemic sclerosis.

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 between 18 and 69 years old?
Have you been diagnosed with systemic sclerosis?
Do you currently have at least one active fingertip ulcer that's 3mm or larger?
Are you able to understand the study information and commit to the visits?
If you know you're taking sildenafil, has it been at a stable dose for at least 2 weeks?
If you're a woman who could become pregnant, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the clinic up to 8 times over a maximum of 31 days. Some of these visits might be over the phone, which can be more convenient. During these visits, the study doctors and nurses will make sure you're safe to continue in the study. They'll apply the study medicine (TOP-N53 or the placebo) to your fingertip ulcer and check on any health issues that might come up.

They will also do various tests before and after treatment to see if the medicine is working. You'll play a vital role by keeping a daily diary. In this diary, you'll answer questions about your symptoms, like pain and itching, at different times before and after you use the medicine. This helps the researchers understand how you're feeling and whether the treatment is making a difference.

Potential risks and benefits

Taking part in a clinical trial may have some potential benefits, such as receiving a new treatment that isn’t widely available and getting close medical monitoring. However, there are also potential risks, like experiencing side effects from the study medicine, even though lower doses are tested first. The study medicine might not help your condition, and there's always a chance of discomfort from clinic visits or procedures. You will be fully informed of all known risks before you decide to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Centre Hospitalier Universitaire de Bordeaux, Service de Rhumatologie
Verified postcode
Bordeaux, France· Recruiting
CHU Grenoble Alpes
Verified postcode
La Tronche, France· Recruiting
CHRU Lille, Hôpital Claude Huriez, Rue Michel Polonosvski
Verified postcode
Lille, France· Recruiting
AP-HP Hôpital Cochin
Verified postcode
Paris, France· Recruiting
Reha Rheinfelden, Salinenstrasse 98
Verified postcode
Rheinfelden, Switzerland· Recruiting

Common questions

What is systemic sclerosis?

Systemic sclerosis is an uncommon condition that causes skin to become hard and tight. It can also affect internal organs and blood vessels in the body.

What are digital ulcers?

Digital ulcers are open sores that appear on the fingertips. They can be painful and may struggle to heal, especially for people with systemic sclerosis.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but contains no active drug. It helps researchers compare the effects of the actual medicine.

How long will I be in the study?

If you participate, you will have up to 8 clinic visits over a maximum of 31 days, with some visits potentially done by phone.

Can I leave the study at any time?

Yes, you have the right to stop participating in the study at any point, for any reason, and it will not affect your regular medical care.

How to find out more

Claudia Berger, Ph.D.

claudia.berger@topadur.com +41792025755 Official trial record

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