A Pilot Trial to Evaluate the Efficacy and Safety of Filsuvez in the Treatment of Moderate-to-Severe Epidermolysis Bullosa Simplex
Stanford University
Summary
This pilot study will look at whether the topical Birch Triterpenes (Filsuvez) gel is safe and helpful for adults and children 6 months of age and older who have moderate to severe epidermolysis bullosa simplex (EBS). The study will examine whether the gel can reduce the number of blisters, help wounds heal faster, and improve comfort by reducing pain and itching and making daily activities easier.
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject has a documented diagnosis and confirmed clinical history of EBS. The Investigator will determine subject eligibility based on historical phenotypic presentation of EBS symptoms along with genetic/diagnosis documentation in order to determine EBS severity. * The following skin conditions are required: * A minimum area of \~3% BSA containing active blisters/erosions, and freshly ruptured blisters across 50% of the TLA (as assessed by the PI). Skin erosions, keratoderma, fissures and/or erythema may also be present. * Subjects will be permitted to treat their…
Interventions
- DrugFilsuvez
All the participants will apply Filsuvez about 3% BSA for 3 months.
Location
- Stanford University School of MedicinePalo Alto, California