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NCT05728879 Clinical Trial

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

Cutaneous T Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05728879
Other study ID # STU00217913
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 2025
Est. completion date December 2026

Study information
Verified date March 2024
Source Northwestern University
Contact Dermatology CTU
Phone 312-503-5944
Email NUderm-research@northwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• APR-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.

Locations
Country Name City State
United States Dermatology CTU Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in microbiome species Reduction of Staphylococcus aureus relative abundance between baseline and Week 4 4 weeks
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