Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07756138
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Epidermolysis Bullosa Simplex

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Filsuvez — DRUG
    All the participants will apply Filsuvez about 3% BSA for 3 months.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
Jul 2, 2027
Completion
Jun 18, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Filsuvez
    All the participants will apply Filsuvez about 3% BSA for 3 months and a follow-up visit 2 months later.

Primary Outcome Measure

Change in Blister surface area reduction of the target treatment areas [ Time Frame: From enrollment to the end of treatment at Week12 and Week20 (EOS). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94304
Joyce M. C. Teng, MD PhD (PRINCIPAL_INVESTIGATOR)
Chaw-Ning Lee, MD PHD (SUB_INVESTIGATOR)

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