Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Northwestern University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ble…
Interventions
- Combination ProductAPR-TD011 (RLF-TD011)
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.
Location
- Dermatology CTUChicago, Illinois