MedTrace Logo

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

NCT06594393 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Epidermolysis Bullosa (EB)
  • Dystrophic Epidermolysis Bullosa
  • Junctional Epidermolysis Bullosa

Interventions

DRUG

TCP-25 gel

Topical gel

DRUG

Vehicle (placebo)

Placebo gel

Sponsors & Collaborators

  • Xinnate AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • France
  • Greece
  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06594393 on ClinicalTrials.gov