Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Starting soon · Early Phase 1
Conditions studied: Cutaneous T Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05728879
- Run by
- Northwestern University
- People needed
- 30
- Starts
- 2027-01-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Dermatology CTU — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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