Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
NCT ID: NCT05728879
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-01-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CTCL participants
Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
APR-TD011 (RLF-TD011)
APR-TD011 (RLF-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.
Interventions
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APR-TD011 (RLF-TD011)
APR-TD011 (RLF-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes
* Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics
* Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.
* Agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Xiaolong (Alan) Zhou
Principal Investigator
Locations
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Dermatology CTU
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00217913
Identifier Type: -
Identifier Source: org_study_id
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