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

NCT05728879 | Not Yet Recruiting Early Phase 1 FDA Drug FDA Device

• 1 other identifier: STU00217913
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Change in microbiome species

  Reduction of Staphylococcus aureus relative abundance between baseline and Week 4

  4 weeks

Study Arms (1)

CTCL participants

EXPERIMENTAL

Visits will include screening, pre-treatment (week 0), weeks 4 and 8.

Combination Product: APR-TD011 (RLF-TD011)

Interventions

APR-TD011 (RLF-TD011) COMBINATION_PRODUCT

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.

Also known as: Nexodyn AOS

CTCL participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Dermatology CTU

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Dermatology CTU

CONTACT

312-503-5944; NUderm-research@northwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)