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Filsuvez for Epidermolysis Bullosa Simplex

(FILS-EBS Trial)

Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

JT

Joyce Teng, MD, PhD, FAAD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults and children aged 6 months or older who have moderate to severe epidermolysis bullosa simplex (EBS), including Weber-Cockayne Syndrome. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

Subjects may treat feet to assess plantar blister surface area but blistering on feet is not required
Subject is in good general health without disease or condition that might interfere with EBS lesion evaluation or pose unacceptable risk
Subject's laboratory values are within normal range or abnormal values are not clinically relevant per PI
See 7 more

Exclusion Criteria

Factors interfering with study compliance such as inability to attend visits or perform protocol procedures
Other reasons making subject unsuitable for enrollment as per Investigator opinion
Illness or condition likely to interfere with participation or completion of study as per principal investigator
See 12 more

What Are the Treatments Tested in This Trial?

Interventions

  • Filsuvez

Trial Overview

The study tests Filsuvez, a gel made from birch tree extracts, applied to the skin. Researchers want to see if it can safely reduce blisters, speed up wound healing, lessen pain and itching, and improve daily life for people with EBS.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: FilsuvezExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

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