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

Northwestern University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Cutaneous T Cell Lymphoma

Treatments

Combination Product: APR-TD011 (RLF-TD011)

Study type

Interventional

Funder types

Other

Identifiers

NCT05728879

STU00217913

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.