Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex
ConditionEpidermolysis Bullosa Simplex
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorStanford University
About this trial
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
Qualifiers
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.
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.
Disqualifiers
Any investigational drug or therapy within 30 days.
Systemic steroidal therapy within 30 days.
Topical steroidal therapy in TLA within 14 days (Note: inhaled and ophthalmic products containing steroids are allowed).
Systemic antibiotic therapy within 7 days.
Trial design
Treatments tested in this trial
- Filsuvez
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov