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Aminoglycoside Antibiotic
Gentamicin Sulfate for Epidermolysis Bullosa
Phase 1 & 2
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. JEB patients with nonsense mutations in the LAMB3 gene in either one or two alleles.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will test if gentamicin can be used to treat Herlitz junctional epidermolysis bullosa (H-JEB), an incurable skin disease, by restoring laminin 332 assembly and improving wound closure.
Eligible Conditions
- Epidermolysis Bullosa
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Generation of new hemidesmosomes as assessed by electron microscopy.
Incidence of Treatment-Emergent Adverse Events
Increased laminin beta 3 / laminin 332 expression as assessed by immunofluorescence.
Secondary outcome measures
Improved wound closure.
Reduction in blistering
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,272 Total Patients Enrolled
4 Trials studying Epidermolysis Bullosa
26 Patients Enrolled for Epidermolysis Bullosa
Frequently Asked Questions
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