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

Early Phase 1

Completed

• Conditions: Epidermolysis Bullosa
• Interventions: Combination Product: APR-TD011

• Registration Number: NCT05533866
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Study Start: 2023-02-06
• Primary Completion: 2024-09-24
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EB participants	APR-TD011	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.

Primary Outcome Measures

Name	Time	Method
Change in microbiome species	8 weeks	Reduction of Staphylococcus aureus between baseline and Week 8.

Trial Locations

Locations (1)

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