Clinical Trials

Phase I Clinical Trial of APR-TD011 for Junctional or Dystrophic EB

Date Updated:
EB Type: Junctional or Dystrophic Epidermolysis Bullosa
Name of Company: Relief Therapeutics
Recruitment Status: Completed

About the Study

In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.

Travel stipend may be available; contact NUderm-research@northwestern.edu for more information.

Trial Entry Criteria

Inclusion Criteria:

  • Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa
  • Target wound that has been present for at least 3 weeks and is at least 10 cm2
  • Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa

Exclusion Criteria:

  • Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics
  • Do not agree to avoid bathing or topical application at the target starting the night before the visit.
  • Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.

Contacts & Location

If you have any questions or are interested in participating in this clinical trial, please contact:

Location:

Ann & Robert H. Lurie Children's Hospital of Chicago    
Chicago, Illinois, United States, 60611    

Get more information on ClinicalTrials.gov

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