A Phase 2 interventional study of TCP-25 gel and Vehicle (placebo) in Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, sponsored by Xinnate AB. Recruiting at 13 sites in 7 countries. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Xinnate AB · Phase 2, Interventional, and Treatment
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.
The study will include a Screening Period, a Treatment Period (Days 1 to 56, with study visits conducted every 2 weeks, including the baseline [Day 1], Day 14, Day 28, Day 42, and Day 56 visits) and a Safety Follow-up conducted via a telephone/video call at approximately 14 days after the last dose of the IMP. Patients will undergo efficacy, safety, tolerability, and PK assessments at scheduled visits. For evaluation of the primary efficacy endpoint, a trained clinician will take the images of the index wounds at all scheduled visits from baseline through Day 56 (Visit 6) using 3D digital photography and software for wound measurement.
78 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 21 are open to participants now.
This study's planned enrollment of 32 is above the median of 9 across 55 interventional studies indexed under Epidermolysis Bullosa Dystrophica.
Browse Epidermolysis Bullosa Dystrophica studies →Xinnate AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Epidermolysis Bullosa Dystrophica, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epidermolysis Bullosa. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical gel
Drug: TCP-25 gel
Placebo gel
Drug: Vehicle (placebo)
Topical gel
Placebo gel
Open wound area
Time frame: 56 days
Frequency, intensity, and seriousness of Adverse Events in all treated patients until end of treatment
Time frame: 56 days
Change in procedural pain using the Wong Baker FACES® Pain Rating Scale (0 min -10 max)
Wong Baker FACES pain rating scale uses 6 graphically or cartoon-depicted faces with varying facial expressions that represent no pain (no hurt) (Face 0) to worst pain/hurt that can be imagined (Face 10).
Time frame: 56 days
Change from baseline in clinical impression of overall treatment area
Time frame: 56 days
TCP-25 plasma concentrations
Time frame: 56 days
Number of participants with treatment-related local tolerability assessment at the area of IMP application assessed on a 4-point scale
Time frame: 56 days
Clinically significant changes from baseline in blood pressure until end of treatment
Time frame: 56 days
Number of patients with clinically significant changes from baseline in pulse rate until end of treatment
Time frame: 56 days
Number of patients with clinically significant changes from baseline in physical examination findings until end of treatment
Time frame: 56 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Epidermolysis Bullosa Dystrophica →