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Trial Title:
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
Condition:
Cutaneous T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
APR-TD011 (RLF-TD011)
Description:
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.
Arm group label:
CTCL participants
Other name:
Nexodyn AOS
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults with early-stage mycosis fungoides (stages IA-IB)
- 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:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dermatology CTU
Address:
City:
Chicago
Zip:
60611
Country:
United States
Contact:
Last name:
Dermatology CTU
Phone:
312-503-5944
Email:
NUderm-research@northwestern.edu
Investigator:
Last name:
Alan Zhou
Email:
Principal Investigator
Start date:
January 2025
Completion date:
December 2026
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728879
