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Study on the Effects of TCP-25 Gel for Wound Healing in Patients with Epidermolysis Bullosa

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a rare skin condition called Epidermolysis Bullosa (EB). EB is a group of genetic disorders that cause the skin to be very fragile and to blister easily. The study will specifically look at two types of EB: Dystrophic Epidermolysis Bullosa (DEB) and Junctional Epidermolysis Bullosa (JEB). The treatment being tested is a gel called TCP-25, which is applied directly to the skin. This gel contains a special protein designed to help with wound healing and improve symptoms in patients with DEB or JEB.

The purpose of the study is to evaluate how effective the TCP-25 gel is in promoting wound healing and improving symptoms of EB. The study will also assess the safety and how well patients tolerate the gel. Participants will be randomly assigned to receive either the TCP-25 gel or a similar gel that does not contain the active ingredient. The study will be conducted in a way that neither the participants nor the researchers know which gel is being used, to ensure unbiased results.

Throughout the study, participants will apply the gel to their wounds and attend regular check-ups to monitor their progress. The study will last for several weeks, during which the size of the wounds, any changes in pain levels, and overall skin condition will be observed. The study aims to provide valuable information on the potential benefits of TCP-25 for people living with EB.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a documented diagnosis of dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) through genetic testing or a skin biopsy.

    Patients must be at least 4 years old. Initially, only those 12 years and older are enrolled. Enrollment for ages 4 to 11 will begin after a safety review of patients aged 12 to 18.

  2. Step 2

    Treatment application

    The treatment involves the application of TCP-25 gel on wounds. This gel is applied topically, directly on the wound area.

    The application is performed regularly as per the study protocol, with the aim to evaluate the gel's effectiveness in promoting wound healing and improving symptoms.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, the wound area is monitored to assess the efficacy of the TCP-25 gel compared to a vehicle gel without the active ingredient.

    The primary endpoint is the change in the open wound area by Day 56 relative to the baseline measurement.

  4. Step 4

    Safety and tolerability assessment

    Safety and tolerability are evaluated by monitoring any adverse events, changes in vital signs, and local tolerability at the application site.

    Secondary endpoints include changes in procedural pain, overall treatment area impression, and TCP-25 plasma concentrations.

  5. Step 5

    Completion and follow-up

    The study is estimated to conclude by December 2026. Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

4 criteria

  • Patients must have a documented diagnosis of **DEB** or **JEB**. These are types of **Epidermolysis Bullosa**, a condition that affects the skin.
  • The diagnosis must be confirmed by genetic testing or a skin biopsy with a special test called **immunofluorescence mapping**.
  • Patients must be at least 4 years old. Initially, only those 12 years and older will be enrolled. After a safety review, children aged 4 to 11 may also be included.
  • Patients must have at least one pair of wounds that are similar in size and location, or one large wound that can be divided into two parts for the study.

Who cannot join the trial?

7 criteria

  • Patients who do not have a diagnosis of **Epidermolysis Bullosa**. This is a group of rare skin conditions that cause the skin to be very fragile and to blister easily.
  • Patients who are not within the specified age range for the study. The study includes certain age groups, so participants must fall within these age categories.
  • Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results.
  • Patients who are pregnant or breastfeeding, as the effects of the treatment on unborn babies or infants are not known.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have a known allergy or sensitivity to the study treatment or its ingredients.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

TCP-25 Gel is a topical treatment being studied for its ability to help heal wounds and improve symptoms in patients with a condition called Epidermolysis Bullosa. This condition causes the skin to be very fragile and to blister easily. The gel is applied directly to the skin, and researchers are looking at how well it works to heal the skin and how safe it is for patients to use.

What is already known about the treatment

TCP-25 – This medication is administered topically in the form of a gel. It is currently being studied in a Phase 2 clinical trial to assess its effectiveness and safety for treating Epidermolysis Bullosa, a rare skin condition. The main therapeutic indication is to promote wound healing and alleviate symptoms in patients with Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB). At the molecular level, TCP-25 is designed to enhance skin repair processes, although specific details of its mechanism of action are still under investigation. It is classified pharmacologically as a topical agent aimed at improving skin integrity and healing.

Investigated diseases

Epidermolysis Bullosa – This is a group of rare genetic conditions that cause the skin to be very fragile and to blister easily. Blisters can form in response to minor injuries, heat, or even friction from rubbing or scratching. The condition can affect the skin as well as the mucous membranes, such as the inside of the mouth. There are several types of Epidermolysis Bullosa, including Dystrophic Epidermolysis Bullosa (DEB) and Junctional Epidermolysis Bullosa (JEB), each varying in severity and symptoms. Over time, repeated blistering can lead to scarring and other complications. The condition is present from birth and is lifelong, with symptoms often becoming apparent in infancy or early childhood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515172-12-00Protocol codeTCP25-002Estimated enrolment32 patientsSponsorXinnate AB

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