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

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728879
Collaborator
(none)
30
1
1
14
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: APR-TD011 (RLF-TD011)
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CTCL participants

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

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.
Other Names:
  • Nexodyn AOS
  • Outcome Measures

    Primary Outcome Measures

    1. Change in microbiome species [4 weeks]

      Reduction of Staphylococcus aureus relative abundance between baseline and Week 4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dermatology CTU Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaolong (Alan) Zhou, Principal Investigator, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05728879
    Other Study ID Numbers:
    • STU00217913
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2023