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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital of Skin and Venereal Diseases of Thessaloniki	Thessaloniki	Greece

Other Sites

Site Name	City	Country
Fondazione Luigi Maria Monti	Rome	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Hospital Clinic De Barcelona	Barcelona	Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Uppqmsu Uofaqgpxob Hntoxrzc	Uppsala	Sweden
Fzgxfhyys Pjep Ls Ibsrjzpzeucgi Bkzrusbvc Dvt Hczvbbur Uafkwetxglsvl Lg Pir	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2025
Greece	Recruiting	01.11.2025
Italy	Recruiting	01.11.2025
Spain	Recruiting	01.11.2025
Sweden	Recruiting	01.11.2025

Trial locations

Investigated drugs:

H-GLY-LYS-TYR-GLY-PHE-TYR-THR-HIS-VAL-PHE-ARG-LEU-LYS-LYS-TRP-ILE-GLN-LYS-VAL-ILE-ASP-GLN-PHE-GLY-GLU-OH

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.

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 ID:

2024-515172-12-00

Protocol code:

TCP25-002

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?