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

NCT ID: NCT05533866

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-03-31

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.

Conditions

Epidermolysis Bullosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

APR-TD011

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Nexodyn AOS

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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2022-5523

Identifier Type: -

Identifier Source: org_study_id