Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

Northwestern University (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

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
  • Combination Product: APR-TD011
Early Phase 1

Study Design

Study Type:
Anticipated Enrollment :
17 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • Nexodyn AOS
  • Outcome Measures

    Primary Outcome Measures

    1. Change in microbiome species [8 weeks]

      Reduction of Staphylococcus aureus between baseline and Week 8.

    Eligibility Criteria


    Ages Eligible for Study:
    6 Months and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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 and Locations


    Site City State Country Postal Code
    1 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Amy Paller, Principal Investigator, Northwestern University Identifier:
    Other Study ID Numbers:
    • 2022-5523
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 9, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2022