Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
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.
|Condition or Disease||Intervention/Treatment||Phase|
||Early Phase 1|
Arms and Interventions
|Experimental: EB participants
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.
Primary Outcome Measures
- Change in microbiome species [8 weeks]
Reduction of Staphylococcus aureus between baseline and Week 8.
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
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 and Locations
|1||Ann & Robert H. Lurie Children's Hospital of Chicago||Chicago||Illinois||United States||60611|
Sponsors and Collaborators
- Northwestern University
Study Documents (Full-Text)None provided.