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NCT05533866 · ClinicalTrials.gov registry record · Early Phase 1
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 of Epidermolysis Bullosa, sponsored by Northwestern University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05533866: Completed Early Phase 1 study of Epidermolysis Bullosa, sponsored by Northwestern University.
NCT05533866 is a Early Phase 1 study of Epidermolysis Bullosa that has completed, run by Northwestern University. The registered enrollment target is 15 participants, below the 18-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05533866, a Early Phase 1 study of Epidermolysis Bullosa, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Reduction of Staphylococcus aureus between baseline and Week 8.
Conditions Studied
Interventions
- COMBINATION_PRODUCT APR-TD011
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2025-03-31 |
| Phase | Early Phase 1 |
What the finished NCT05533866 record still lists
NCT05533866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 18-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which APR-TD011 is the first listed.
NCT05533866 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05533866 about?
NCT05533866 is a clinical study titled "Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution". 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...
What is the current status of trial NCT05533866?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2023-02-06. Estimated completion is 2025-03-31.
What conditions does trial NCT05533866 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa.
What interventions are being tested in trial NCT05533866?
The interventions under investigation include: APR-TD011 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05533866?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05533866 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epidermolysis Bullosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05533866's enrollment target sits among peer trials
15 4th of 10 higher than 7 of 10 other Epidermolysis Bullosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epidermolysis Bullosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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