Cutaneous T Cell Lymphoma
Conditions
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.
Interventions
COMBINATION_PRODUCTAPR-TD011 (RLF-TD011)
APR-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.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiome species | 4 weeks | Reduction of Staphylococcus aureus relative abundance between baseline and Week 4 |
Countries
United States
Contacts
CONTACTDermatology CTU
Outcome results
None listed