Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use… (NCT05728879) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
United States30 participantsStarted 2027-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.