CompletedEarly Phase 1

Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution

United States15 participantsStarted 2023-02-06

Plain-language 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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in microbiome species

Timeframe: 8 weeks

Trial details

NCT IDNCT05533866

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-24