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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|ClinicalTrials.gov Identifier: NCT05533866|
Recruitment Status : Enrolling by invitation
First Posted : September 9, 2022
Last Update Posted : March 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Combination Product: APR-TD011||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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|Ages Eligible for Study:||6 Months and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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|
|Other Study ID Numbers:||
|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, Junctional
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Vesiculobullous