An Early Phase 1 interventional study of APR-TD011 in Epidermolysis Bullosa, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Northwestern University · Early Phase 1, Interventional, and Treatment
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.
126 studies on the registry are indexed under Epidermolysis Bullosa; 23 are open to participants now.
This study's enrollment of 15 is above the median of 11 across 95 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Visits will include screening, pre-treatment (week 0), weeks 4 and 8, followed by a visit without use of the APR-TD011 for 4 weeks (week 12) for microbiome assessment off of therapy.
Combination Product: APR-TD011
APR-TD011 wound cleansing spray (drug/device combination product with a 510k clearance that is commercially marketed in the US for use by or on the order of a physician. Based on its product profile, APR-TD011 has been granted an FDA Orphan Drug Designation for epidermolysis bullosa.
Also known as: Nexodyn AOS
Change in microbiome species
Reduction of Staphylococcus aureus between baseline and Week 8.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Northwestern University