RecruitingNot ApplicableInterventional

Topical alprostadil in patients with systemic sclerosis

This study is exploring a new way to treat problems with blood vessels in the fingers, common in people with Systemic Sclerosis (also known as scleroderma). Currently, treatments often mean hospital stays and unpleasant side effects. Researchers are testing an alprostadil cream applied to the skin to see if it can increase blood flow in the fingers. This could offer a more convenient and gentler treatment option at home. The study involves a single visit to Salford Royal Hospital, where different creams will be applied to your fingers, and measurements will be taken to see how blood flow changes. There are no direct benefits to participants, but your involvement will help scientists understand scleroderma better.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Manchester

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Sep 2026

Systemic Sclerosis (SSc), scleroderma

What is this study about?

If you have Systemic Sclerosis, you might experience issues with blood flow in your fingers and hands, like Raynaud's phenomenon (where your fingers go cold, numb, or change colour), or even painful sores. Current treatments for these problems usually involve going to the hospital for several days to receive medication through a drip into your arm. These treatments can have side effects and aren't always easy to manage.

Researchers are looking for new, gentler ways to treat these blood flow problems. This study is investigating a cream containing a medicine called alprostadil. They want to see if applying this cream directly to the skin of the fingers can make more blood flow into them. This is important because if it works, it could lead to new, easier-to-use treatments that you could apply at home, avoiding hospital stays and potentially reducing side effects.

The main goal of this particular study is to understand how the body reacts to the cream. It's an early step to gather information, rather than directly treating your condition. By understanding how alprostadil affects blood flow in the fingers, doctors can decide if it's a promising treatment to investigate further in larger studies.

Key takeaways

Exploring a new cream (alprostadil) for blood flow problems in scleroderma.
Aims to find a more convenient and gentler treatment than current options.
Involves a single, two-hour visit to Salford Royal Hospital.
No direct benefit for participants, but vital for future research.
Possible minor side effect: a slight rash.
Your medical care will not be affected if you choose not to participate.

Who may be eligible?

This study is looking for people who have a confirmed diagnosis of Systemic Sclerosis (scleroderma) and are 18 years old or older. You must also receive your care at Salford Royal Hospital to be able to take part.

There are some reasons why you might not be able to join. For instance, if you currently have open sores or ulcers on your fingers. Also, if you are receiving certain treatments through a drip for your blood vessel problems, or if you are waiting for surgery for these issues, you wouldn't be eligible. You also need to have been on a stable dose of any other regular blood vessel medication for at least two weeks before the study.

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 you have a diagnosis of Systemic Sclerosis?
Are you aged 18 or older?
Do you receive your medical care at Salford Royal Hospital?
Do you currently have any open sores on your fingers?
Are you receiving treatments through a drip for your blood vessel problems?
Have you been on a stable dose of any regular blood vessel medications for the past two weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to come to Salford Royal Hospital for a single visit, which will last about two hours in the morning. First, you'll sign a consent form, which means you understand what the study involves and agree to participate. The researchers will also collect some information about your health and measure the thickness of the skin on your fingers, both by hand and using a special ultrasound machine.

During the visit, creams will be applied to three of your fingers (your index, middle, and ring fingers). One finger will receive the alprostadil cream, another will get a dummy cream (placebo) with no active medicine, and one finger will have no cream applied. The creams will be rubbed into the back of your fingers by the study team for about 60 seconds. Before, immediately after, and then every 10 minutes for 90 minutes following the cream application, the team will measure the blood flow and temperature in your fingers using special imaging techniques.

Potential risks and benefits

This study isn't designed to directly benefit you, but your participation is very important to help researchers learn more about scleroderma and how best to treat it in the future. The cream is only applied once, so it's unlikely to have a lasting effect on your condition. The risks are expected to be very small. The study cream, alprostadil, is a licensed medicine for other conditions and is being used here to see if it increases blood flow in fingers. The only known side effect when applied to the skin might be a slight rash. You are free to stop participating at any time during the study without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northern Care Alliance NHS Foundation Trust
City only
Salford, United Kingdom

Common questions

What is Systemic Sclerosis (Scleroderma)?

It's a long-term condition that affects the body's connective tissue, sometimes causing problems with blood vessels, especially in the fingers and hands.

Why is this study important if it doesn't directly help me?

It helps doctors understand how new treatments might work, which could lead to better medicines for people with scleroderma in the future.

Will I know which cream I'm getting?

No, the creams (active, dummy, and no treatment) are applied in a random, usually 'blinded' way, so neither you nor the researchers know which finger gets what until after the study is complete, to ensure fair results.

How long will the study last in total?

The study itself is expected to run for about 12 months, starting in October 2025. Your involvement would be for a single, two-hour visit.

Who is running and paying for this study?

The study is led by Dr. Michael Hughes and run by the Scleroderma Research Group at Salford Royal Hospital. It's funded internally by NIHR Manchester, Biomedical Research Centre (BRC).

How to find out more

Paul New

paul.new2@nca.nhs.uk +44 161 206 4295 Official trial record

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