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_PRODUCT
    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.

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 participants
    Visits will include screening, pre-treatment (week 0), weeks 4 and 8.

Primary Outcome Measure

Change in microbiome species [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dermatology CTUChicagoIllinois60611
Dermatology CTU
312-503-5944
Alan Zhou (PRINCIPAL_INVESTIGATOR)

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