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NCT Number: NCT05728879

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dermatology CTU

Chicago, Illinois, 60611, United States

Location contact

Alan Zhou

PRINCIPAL_INVESTIGATOR

Dermatology CTU

CONTACT

[email protected]

312-503-5944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Nexodyn AOS

Primary outcomes

  1. Change in microbiome species

    Time frame: 4 weeks

    Reduction of Staphylococcus aureus relative abundance between baseline and Week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Dermatology CTU

CONTACT

[email protected]

312-503-5944

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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