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

Northwestern University2 sites in 1 country30 target enrollmentJanuary 1, 2027

ConditionsCutaneous T Cell Lymphoma

InterventionsAPR-TD011 (RLF-TD011)

Overview

Phase: Early Phase 1
Intervention: APR-TD011 (RLF-TD011)
Conditions: Cutaneous T Cell Lymphoma
Sponsor: Northwestern University
Enrollment: 30
Locations: 2
Primary Endpoint: Change in microbiome species
Status: Not yet recruiting
Last Updated: yesterday

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 1, 2027

End Date

December 1, 2028

Last Updated

yesterday

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Xiaolong (Alan) Zhou

Principal Investigator

Northwestern University

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.