Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution

Launched by NORTHWESTERN UNIVERSITY · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a special spray called APR-TD011 on skin lesions caused by a type of cancer known as Cutaneous T Cell Lymphoma (CTCL). The study aims to understand how well patients tolerate the spray and how it might change the bacteria on their skin before and after using it. This is an early-stage trial, and it is not yet open for participants.

To be eligible for this study, participants need to be adults diagnosed with an early stage of a specific type of CTCL called mycosis fungoides. They should have at least two skin lesions that have been present for at least three weeks. Additionally, one of these lesions must test positive for a type of bacteria known as Staphylococcus aureus, but not at a level that requires antibiotics. Participants will need to avoid washing or using other topical treatments on the lesions before each visit and refrain from certain antiseptics during the study. If you or someone you know fits this description and is interested in participating, they can expect close monitoring while using the spray and contributing to important research on CTCL treatment.

Gender

ALL

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.