~1 spots leftby Apr 2026

Gentamicin for Junctional Epidermolysis Bullosa

Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Southern California
No Placebo Group

Trial Summary

What is the purpose of this trial?

Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes, resulting in loss of laminin 332 and poor epidermal-dermal adherence. Eighty percent of H-JEB patients have LAMB3 mutations and about 95% of these are nonsense mutations. The investigators recently demonstrated that gentamicin readily induced nonsense mutation readthrough and produced full-length laminin beta3 in several nonsense mutations tested. Importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion, and deposition into the dermal-epidermal junction (DEJ). Newly induced laminin 332 reversed abnormal H-JEB cellular phenotypes. Herein, the investigators propose the first clinical trial of gentamicin (by topical and intravenous administration) in JEB patients with nonsense mutations. The milestones will include restored laminin 332 and hemidesmosomes at the DEJ, improved wound closure, and the absence of significant gentamicin side effects.

Eligibility Criteria

Inclusion Criteria

1. JEB patients with nonsense mutations in the LAMB3 gene in either one or two alleles.

Treatment Details

Interventions

  • Gentamicin Sulfate (Aminoglycoside Antibiotic)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Gentamicin SulfateExperimental Treatment1 Intervention
IV Arm: 7.5 mg/kg gentamicin once daily for 14 days. Topical Arm: 0.5% gentamicin ointment applied twice daily for 14 days to selected skin sites.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?

University of Southern CaliforniaLead Sponsor

References