APR-TD011 for Epidermolysis Bullosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL
Epidermolysis Bullosa+1 More
APR-TD011 - CombinationProduct
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Epidermolysis Bullosa

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Epidermolysis Bullosa

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 8 weeks

8 weeks
Change in microbiome species

Trial Safety

Safety Progress

1 of 3

Other trials for Epidermolysis Bullosa

Trial Design

1 Treatment Group

EB participants
1 of 1
Experimental Treatment

17 Total Participants · 1 Treatment Group

Primary Treatment: APR-TD011 · No Placebo Group · Phase < 1

EB participants
CombinationProduct
Experimental Group · 1 Intervention: APR-TD011 · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
Closest Location: Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2015First Recorded Clinical Trial
2 TrialsResearching Epidermolysis Bullosa
145 CompletedClinical Trials

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,421 Previous Clinical Trials
717,360 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
18 Patients Enrolled for Epidermolysis Bullosa

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 6 months of age or older.
You have a wound that has been present for at least 3 weeks and is at least 10 cm2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.