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Does a Wound-Healing gel raise cancer risk? new study aims to find out

NCT ID NCT06423573

Knowledge-focused Sponsor: Amryt Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 580 people with dystrophic or junctional epidermolysis bullosa (EB) for up to 5 years. Researchers want to see if using Filsuvez, a birch bark extract gel that helps heal blisters, changes the risk of developing skin cancer. Participants receive standard care, with or without Filsuvez, and are monitored for new skin malignancies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Filsuvez (birch bark extract gel)
What this could lead to
If it shows that Filsuvez does not increase skin cancer risk, it would support its safe long-term use for wound healing in epidermolysis bullosa.
What could go wrong
This is an observational study, not a controlled trial, so it can only suggest links, not prove cause and effect. Results may take years and could be inconclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 580 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with dystrophic EB or junctional EB, whether they are receiving Filsuvez, receiving another treatment for EB, or not receiving any treatment.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with a confirmed diagnosis of dystrophic EB or junctional EB Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

dystrophic epidermolysis bullosa, dog epidermolysis bullosa dystrophica junctional epidermolysis bullosa skin cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epidermolysis bullosa, dystrophic Epidermolysis bullosa, junctional

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Toulouse, Hôpital Larrey

    RECRUITING

    Toulouse, France

  • Guy's and St Thomas' NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Hospital Clinic, Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital San Juan de Dios (Barcelona)

    RECRUITING

    Barcelona, Spain

  • Hospital of Skin and Venereal Diseases of Thessaloniki

    RECRUITING

    Thessaloniki, Greece

More trials for these conditions

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