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NCT07756138
Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex
Conditions: Epidermolysis Bullosa Simplex
Sex: All
Ages: 6 Months – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Stanford University
Location: Stanford University School of Medicine Palo Alto California
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 Criteria
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 feet to assess plantar blister surface area but blistering on the feet is not a requirement for study inclusion.
* TLA may not be infected (as assessed by PI) or have been treated with a topical antibiotic within 14 days.
* If the subject is a woman of childbearing potential (WOCBP) (Need to verify current labeling on use during pregnancy)
* Has a negative urine pregnancy test at baseline.
* Agrees to use an approved effective form of birth control with failure rates \
Source: ClinicalTrials.gov (NCT07756138). StuddyBuddy aggregates publicly available trial information.