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Antimicrobial Wound Cleansing Spray

Antimicrobial Wound Cleansing Spray for Epidermolysis Bullosa

Q: Are researchers currently enrolling participants in this experiment?

<p>Unfortunately, according to the clinicaltrials.gov listing this trial is not currently enrolling patients. It was initially posted on October 1st 2022 and last refreshed on September 6th of that same year. Nevertheless, 28 other medical trials are still accepting participants at present.</p>

Phase < 1

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial is testing an antimicrobial wound cleansing spray for people with junctional EB or dystrophic epidermolysis bullosa who have wounds that are positive for culture of Staphylococcus aureus or Pseudomonas aeruginosa. The primary aim is to evaluate the change in skin microbiome (bacteria that live on the skin) before, during, and after treatment.

Who is the study for?

This trial is for patients aged 6 months or older with junctional or dystrophic epidermolysis bullosa who have a wound at least 10 cm2 in size that's been present for over 3 weeks and is infected with Staphylococcus aureus or Pseudomonas aeruginosa. It excludes those on recent antibiotics, using antiseptics, bleach/vinegar baths, or topical treatments at the target site.Check my eligibility

What is being tested?

The study tests APR-TD011 antimicrobial spray on wounds of people with JEB/DEB to see how it affects skin bacteria before, during, and after an 8-week treatment period. Participants will then stop using the spray for four weeks followed by a six-month open-label use phase where they can choose to use the spray as desired.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions typical of topical treatments such as skin irritation, redness, itching or allergic reactions due to sensitivity to ingredients in the APR-TD011 spray solution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 6 months old and have junctional or dystrophic epidermolysis bullosa.

Select...

My wound is at least 3 weeks old and covers an area of 10 cm2 or more.

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My wound is infected with Staphylococcus aureus or Pseudomonas aeruginosa.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in microbiome species

Trial Design

1Treatment groups

Experimental Treatment

Group I: EB participantsExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,214 Total Patients Enrolled

3 Trials studying Epidermolysis Bullosa

38 Patients Enrolled for Epidermolysis Bullosa

Media Library

APR-TD011 (Antimicrobial Wound Cleansing Spray) Clinical Trial Eligibility Overview. Trial Name: NCT05533866 — Phase < 1

Epidermolysis Bullosa Research Study Groups: EB participants

Epidermolysis Bullosa Clinical Trial 2023: APR-TD011 Highlights & Side Effects. Trial Name: NCT05533866 — Phase < 1

APR-TD011 (Antimicrobial Wound Cleansing Spray) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05533866 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants in this experiment?

"Unfortunately, according to the clinicaltrials.gov listing this trial is not currently enrolling patients. It was initially posted on October 1st 2022 and last refreshed on September 6th of that same year. Nevertheless, 28 other medical trials are still accepting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Amy Paller 2023. "Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05533866.

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