Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT05728879
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Cutaneous T Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- APR-TD011 (RLF-TD011) — COMBINATION_PRODUCTAPR-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.
Study Details
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.
Key Dates
- Start date
- Jan 31, 2027
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CTCL participantsVisits will include screening, pre-treatment (week 0), weeks 4 and 8.
Primary Outcome Measure
Change in microbiome species [ Time Frame: 4 weeks ]
Central Contacts
- Dermatology CTU312-503-5944
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dermatology CTU | Chicago | Illinois | 60611 | Alan Zhou (PRINCIPAL_INVESTIGATOR) |
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