Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
NCT05728879 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-01
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-01-31
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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