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.
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.
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.
Single group
APR-TD011 (RLF-TD011)
Combination productAPR-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.
Change in microbiome species
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
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This trial is not recruiting at the moment. You can still explore other options:
