Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Study Details
Study Description
Brief Summary
This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the treatment of CTCL skin lesions.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CTCL participants Visits will include screening, pre-treatment (week 0), weeks 4 and 8. |
Combination Product: 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 Names:
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Outcome Measures
Primary Outcome Measures
- Change in microbiome species [4 weeks]
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults with early-stage mycosis fungoides (stages IA-IB)
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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
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Target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics
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Agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit.
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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:
- Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Dermatology CTU | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00217913