Epidermolysis BullosaEarly Phase 1NCT05533866
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
A Early Phase 1 study testing APR-TD011 in people with Epidermolysis Bullosa, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- APR-TD011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 31 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Epidermolysis Bullosa
- Being tested
- APR-TD011
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APR-TD011Combination product
Also called Nexodyn AOS
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 group | Role | What they receive |
|---|---|---|
| EB participants | Experimental | 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. Receives: Combination Product: APR-TD011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome species
Reduction of Staphylococcus aureus between baseline and Week 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start6 Feb 2023
- Primary completion24 Sep 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533866
- Sponsor's protocol ID
- 2022-5523
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
- ClinicalTrials.gov ID
- NCT05533866
- Acronym / sponsor ID
- 2022-5523
- Conditions
- Epidermolysis Bullosa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EB participants | Experimental | Combination Product: APR-TD011Visits 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APR-TD011Also: Nexodyn AOSAPR-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. | Combination product | EB participants |
Primary outcome
Change in microbiome species
Time frame: 8 weeks
Reduction of Staphylococcus aureus between baseline and Week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing APR-TD011 in people with Epidermolysis Bullosa, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome species (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.