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New gel could ease pain and heal wounds for kids with butterfly skin

NCT ID NCT06594393

Symptom relief Sponsor: Xinnate AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests a gel called TCP-25 on people with epidermolysis bullosa (EB), a condition that causes fragile skin and painful blisters. About 32 people aged 4 and older with certain types of EB will have two matching wounds treated—one with the study gel and one with a placebo gel. The goal is to see if the gel helps wounds close faster and reduces pain during dressing changes.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

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

Started

Jan 2026

Expected to finish

Jun 2027

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.

Ages

4 years and older

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: * Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping. * Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use. Exclusion Criteria: * The patient has any subtype of EB other than DEB or JEB. * The patient is currently being treated or planned to be treated with systemic antibiotics. Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited. • Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit. Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted. • The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.

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Conditions

The condition(s) this trial relates to.

dystrophic epidermolysis bullosa, dog epidermolysis bullosa epidermolysis bullosa dystrophica junctional epidermolysis bullosa

As listed by the trial registrant

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

Dystrophic epidermolysis bullosa Epidermolysis bullosa (EB) Junctional epidermolysis bullosa

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 6 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Akademiska sjukhuset

    RECRUITING

    Uppsala, Sweden

  • Andreas Syngros Hospital of Veneral & Dermatological Diseases

    RECRUITING

    Athens, Greece

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Hopital St Louis

    RECRUITING

    Paris, France

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Of Skin And Venereal Diseases of Thessaloniki

    RECRUITING

    Thessaloniki, Greece

  • Hospital Univ La Paz

    RECRUITING

    Madrid, Spain

  • IDI Istituto Dermopatico dell'Immacolata IRCCS

    RECRUITING

    Rome, Italy

  • San Joan de Deu, SJD Children's hospital Barcelona

    RECRUITING

    Barcelona, Catalonia, Spain

  • University hospital

    RECRUITING

    Lund, Skåne County, 23735, Sweden

    Contact Email: •••••@•••••

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