AuthorisedTherapeutic exploratory (Phase II)Interventional

SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds

This research study, called SCARFREE-001, is exploring a new way to prevent scars after surgery. It's looking at a medicine called verteporfin, given as a tiny injection into the skin. The study wants to find the best dose of verteporfin (0.5, 1.0, or 2.0 mg/mL) that helps reduce scarring. We'll be comparing how well these doses work against a dummy treatment (saline) in two types of wounds: standard surgical cuts that are sewn together and small skin samples taken for research. The main goal is to see if verteporfin can improve the look and quality of scars three months after surgery. This is a Phase II study, meaning it's an early stage of testing to see if the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

Start

13 May 2026

Scar formation following surgical wounds

What is this study about?

When we have surgery, our bodies naturally heal by forming a scar. Sometimes these scars can be quite noticeable or uncomfortable. This study is looking into a new treatment called verteporfin, which might help to make scars less obvious or better quality. The researchers want to see if giving verteporfin as a small injection into or around a surgical wound can reduce scarring compared to not giving anything, or giving a simple salt-water injection (which acts as a placebo).

To do this, they will be testing different amounts, or doses, of verteporfin: 0.5, 1.0, and 2.0 milligrams per millilitre. They'll be looking at two main types of wounds: surgical cuts that are stitched closed, and very small skin samples called "punch biopsies." The main way they'll check if the treatment works is by using a special scoring system called the Patient and Observer Scar Assessment Scale (POSAS). A trained person will look at the scars three months after the treatment to see if there's a difference in their quality.

Besides looking at scar quality, the study will also check for safety. This means they will keep a close eye on any side effects, like redness or irritation, and see how well people tolerate the treatment. They'll also take photographs and use ultrasound (like a scan) to measure scar thickness, see how quickly open wounds heal, and ask participants how happy they are with their scars using special questionnaires.

Key takeaways

This study evaluates a new treatment (verteporfin) for reducing surgical scars.
It tests different doses of the treatment against a placebo (dummy) injection.
Both closed (stitched) and open (biopsy) wounds are being studied.
Scar quality will be assessed after three months.
The study also monitors safety and patient satisfaction.

Who may be eligible?

This study is looking for adults aged 18 years and above. There is no upper age limit, meaning older adults are welcome to participate if they meet other health criteria.

Both men and women can take part in this research. The study needs a diverse group of participants to get a good understanding of how the treatment works across different people.

More specific health checks will be done by the study team to make sure it's safe for you to take part. For example, they'll check your general health and that you're well enough for the surgery or biopsy that is part of 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.

Are you 18 years old or older?
Are you male or female?
Are you generally healthy enough to have surgery or a small biopsy?
Are you able to attend follow-up appointments for about three months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have a surgical wound or a small skin biopsy as part of the study. Immediately after, you would receive small injections of either verteporfin (one of the three doses) or a dummy treatment (saline) directly into or around the wound. You'd likely have several follow-up visits over a few months. During these visits, the study team would check your wound, look for any side effects, and take photos to assess the scar. They would also use special surveys to ask about your comfort and how you feel about the scar. The total duration of your participation, including follow-up appointments, would be around three months.

Potential risks and benefits

Taking part in this study could potentially lead to clearer, less noticeable scars, which might improve how you feel about your surgical outcome. However, new treatments always carry risks, and you might experience mild side effects like redness, swelling, or pain at the injection site. There's also no guarantee that the treatment will work for you, and your scar might not improve. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is verteporfin?

Verteporfin is a medicine being tested to see if it can help reduce scarring after surgery. It's given as a small injection into the skin around the wound.

What does 'Phase II study' mean?

Phase II means this is an early stage of research where doctors are testing the treatment in a small group of people to see if it's effective and safe, and to find the right dose.

Will I know if I'm getting the real medicine or the dummy treatment?

No, in this type of study, neither you nor the researchers will know who is receiving the verteporfin and who is receiving the dummy treatment. This helps ensure fair and unbiased results.

How will my scar be measured?

Your scar will be assessed using a special scoring system called POSAS, where a trained person will look at it. We'll also take photographs and possibly use ultrasound to measure its thickness.

What if I experience side effects?

The study team will closely monitor you for any side effects. If you experience anything unusual or concerning, you should tell them immediately so they can provide appropriate care.