Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Primary Purpose
Epidermolysis Bullosa
Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
APR-TD011
Sponsored by
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa
Eligibility 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.
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EB participants
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in microbiome species
Reduction of Staphylococcus aureus between baseline and Week 8.
Secondary Outcome Measures
Full Information
NCT ID
NCT05533866
First Posted
September 6, 2022
Last Updated
March 2, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05533866
Brief Title
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Official Title
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EB participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
APR-TD011
Other Intervention Name(s)
Nexodyn AOS
Intervention Description
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 Measure Information:
Title
Change in microbiome species
Description
Reduction of Staphylococcus aureus between baseline and Week 8.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
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