Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-01 @ 10:59 PM
Study NCT ID:
NCT05533866
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2022-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in microbiome species', 'timeFrame': '8 weeks', 'description': 'Reduction of Staphylococcus aureus between baseline and Week 8.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Epidermolysis Bullosa']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa\n* Target wound that has been present for at least 3 weeks and is at least 10 cm2\n* Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa\n\nExclusion Criteria:\n\n* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics\n* Do not agree to avoid bathing or topical application at the target starting the night before the visit.\n* Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.'}, 'identificationModule': {'nctId': 'NCT05533866', 'briefTitle': 'Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution', 'orgStudyIdInfo': {'id': '2022-5523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EB participants', 'description': '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.', 'interventionNames': ['Combination Product: APR-TD011']}], 'interventions': [{'name': 'APR-TD011', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Nexodyn AOS'], 'description': '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.', 'armGroupLabels': ['EB participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amy Paller', 'investigatorAffiliation': 'Northwestern University'}}}}