A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Xinnate AB · NCT06594393
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 4+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 32
- US sites recruiting
- 1
- Study start
- January 30, 2026
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: TCP-25 gel; Vehicle (placebo)
Conditions: Epidermolysis Bullosa (EB); Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping.
- Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.
Exclusion Criteria
- The patient has any subtype of EB other than DEB or JEB.
- The patient is currently being treated or planned to be treated with systemic antibiotics.
Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.
- Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.
Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
- The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.
Recruiting US locations
Cincinnati Children's Hospital Medical Center
Cincinnati, OH 45229
Site contact: Dr. Kalyani Marathe, PI, MD · kalyani.marathe@cchmc.org
Study contacts (from the official record)
- Head of Clinical Development · 46462756000 · info@xinnate.com