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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • APR-TD011 (RLF-TD011)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators