Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05533866 |
Recruitment Status :
Enrolling by invitation
First Posted : September 9, 2022
Last Update Posted : March 3, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epidermolysis Bullosa | Combination Product: APR-TD011 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution |
Actual Study Start Date : | February 6, 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | May 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Combination Product: 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.
Other Name: Nexodyn AOS |
- Change in microbiome species [ Time Frame: 8 weeks ]Reduction of Staphylococcus aureus between baseline and Week 8.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05533866
United States, Illinois | |
Ann & Robert H. Lurie Children's Hospital of Chicago | |
Chicago, Illinois, United States, 60611 |
Responsible Party: | Amy Paller, Principal Investigator, Northwestern University |
ClinicalTrials.gov Identifier: | NCT05533866 |
Other Study ID Numbers: |
2022-5523 |
First Posted: | September 9, 2022 Key Record Dates |
Last Update Posted: | March 3, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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.: | No |
Epidermolysis Bullosa Epidermolysis Bullosa, Junctional Skin Abnormalities Congenital Abnormalities |
Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases Skin Diseases, Vesiculobullous |