A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a topical gel called TCP-25 in patients with confirmed Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB). This Phase 2 study uses a randomized, double-blind, vehicle-controlled design where pairs of matching wounds on each patient are treated either with TCP-25 gel or a placebo gel. The study aims to better understand how this treatment works on open wounds in these conditions. Participants will go through a Screening Period followed by a 56-day Treatment Period with visits every two weeks, including baseline, Day 14, Day 28, Day 42, and Day 56. During treatment, each patient's wounds will receive either the TCP-25 gel or the placebo gel. After treatment, a Safety Follow-up will be conducted through a phone or video call about two weeks later to assess any lasting effects or concerns. Throughout the study, patients will have their wounds photographed using 3D digital imaging at each visit to measure wound size and healing. Researchers will monitor safety through adverse event reporting, physical exams, and blood pressure and pulse checks. Pain levels will be assessed using the Wong Baker FACES Pain Rating Scale. Blood samples will be collected to analyze TCP-25 levels in the plasma. The total participation time for each patient is roughly two months plus the follow-up call.

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