Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Early Phase 1
Not yet recruiting
- Conditions
- Cutaneous T Cell Lymphoma
- Interventions
- Combination Product: APR-TD011 (RLF-TD011)
- Registration Number
- NCT05728879
- Lead Sponsor
- Northwestern University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CTCL participants APR-TD011 (RLF-TD011) Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
- Primary Outcome Measures
Name Time Method Change in microbiome species 4 weeks Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dermatology CTU
🇺🇸Chicago, Illinois, United States