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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Improved wound closure.
Reduction in blistering

Side effects data

From 2023 Phase 2 & 3 trial • 23 Patients • NCT03503513
63%
Urinary Tract Infection
21%
COVID-19
16%
flu-like symptoms
16%
bladder spasms
11%
Clinically significant labs
11%
abdominal stoma issue
11%
GI upset
11%
heel wound
5%
bowel obstruction
5%
Serratia tissue infection
5%
loose stool
5%
hematuria
5%
inguinal pain
5%
parotitis
5%
vaginitis
5%
muscle strain
5%
Gross hematuria
5%
nasal discharge
5%
bladder stone
5%
bone infection
5%
bladder irritation
5%
bleeding from catheter site
5%
pneumonia
5%
conjunctivitis
5%
sweating
5%
urinary discharge
5%
pulmonary embolism
5%
Post-COVID 19 pneumonia
5%
cystolitholapaxy
5%
Renal stone removal
5%
air in bladder
5%
upper respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gentamicin Sulfate

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
944 Previous Clinical Trials
1,604,639 Total Patients Enrolled
4 Trials studying Epidermolysis Bullosa
26 Patients Enrolled for Epidermolysis Bullosa
~1 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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