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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05533866

Enrollment

Registered

2022-09-09

Start date

2023-02-06

Completion date

2025-03-31

Last updated

2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis Bullosa

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.

Interventions

COMBINATION_PRODUCTAPR-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in microbiome species	8 weeks	Reduction of Staphylococcus aureus between baseline and Week 8.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026