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01
Overview
Phase 2, randomised, double-blind trial in epidermolysis bullosa (EB) comparing TCP-25 with Vehicle (2 arms). Primary endpoint: Open wound area at 56 days. Started Jan 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
TCP-25
Topical gel applied to one of the matching index wounds
Vehicle
Placebo gel applied to the other matching index wound
03
Who it enrols
Patients >= 4 years old with confirmed DEB or JEB, excluding those on systemic antibiotics or recent topical antibiotics/corticosteroids, and those with malignancy over the index wound.
04
Endpoints
Primary
Open wound area
Secondary
Adverse Events
Procedural pain using Wong Baker FACES Pain Rating Scale
Clinical impression of overall treatment area
TCP-25 plasma concentrations
Treatment-related local tolerability assessment
Clinically significant changes from baseline in blood pressure
Clinically significant changes from baseline in pulse rate
Clinically significant changes from baseline in physical examination findings
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