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New treatment option for Epidermolysis Bullosa (EB)
Official title A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
ClinicalTrials.gov ID: NCT06594393
What this study is testing
What is TCP-25 gel?
TCP-25 gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for epidermolysis bullosa (eb).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds...
- The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Athens, Greece
- Thessaloniki, Greece
- Rome, Italy
- Barcelona, Catalonia, Spain
- Barcelona, Spain
- Madrid, Spain
- Lund, Skåne County, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Athens, Greece; Thessaloniki, Greece; Rome, Italy; Barcelona, Catalonia, Spain; Barcelona, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.