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

Northwestern University

Status and phase: Completed; Early Phase 1

Conditions: Epidermolysis Bullosa

Treatments: Combination Product: APR-TD011

Study type: Interventional

Funder types: Other

Identifiers

NCT05533866

2022-5523

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 6+ months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EB participants

Experimental group

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.

Treatment:

Combination Product: APR-TD011