Actively Recruiting
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Led by Xinnate AB · Updated on 2026-01-29
32
Participants Needed
6
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or skin biopsy with immunofluorescence mapping
- Patients 4 years old or older
- Enrollment initially limited to patients 12 years and older, with extension to ages 4 to 11 after safety review by DMC
You will not qualify if you...
- Patients with any subtype of EB other than DEB or JEB
- Currently treated or planned treatment with systemic antibiotics
- Use of topical antibiotics on index wounds within 7 days before baseline visit
- Use of systemic corticosteroids >0.2 mg/kg prednisone equivalent per day within 30 days or topical corticosteroids on index wounds within 7 days before screening visit
- History of or current malignancy over the index wound such as basal cell carcinoma or squamous cell carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hopital St Louis
Paris, France
Actively Recruiting
2
Andreas Syngros Hospital of Veneral & Dermatological Diseases
Athens, Greece
Actively Recruiting
3
Hospital Of Skin And Venereal Diseases of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
4
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
5
Hospital Univ La Paz
Madrid, Spain
Actively Recruiting
6
University hospital
Lund, Skåne County, Sweden, 23735
Not Yet Recruiting
Research Team
H
Head of Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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