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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

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

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.

Data Monitoring Committee

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

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

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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