Phase 2 Study of TCP-25 Gel for Treating Epidermolysis Bullosa Including Dystrophic and Junctional Types

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of a topical gel called TCP-25 in patients diagnosed with two types of Epidermolysis Bullosa, specifically Dystrophic and Junctional forms. This Phase 2, double-blind, randomized, vehicle-controlled study uses a design where matching wounds on the same patient are treated with either TCP-25 gel or a placebo gel to compare effects directly. Participants will undergo a Treatment Period lasting 56 days, during which they will apply either TCP-25 gel or placebo gel locally on designated wounds. Study visits occur every two weeks at baseline Day 1, and on Days 14, 28, 42, and 56. After treatment, a Safety Follow-up via telephone or video call is conducted approximately two weeks post last dose. Wound assessments include 3D digital photography and software measurements taken at all scheduled visits. During the study, participants will have evaluations for wound healing, safety, tolerability, and pharmacokinetics. Clinicians capture detailed images of wounds to measure open wound area and monitor changes. Pain levels, treatment-related local reactions, vital signs, and adverse events are regularly assessed. The total participation time includes screening, 56 days of treatment with five clinic visits, and a follow-up call about two weeks after treatment ends.

A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study