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Not yet recruiting NCT05728879

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

Early Phase I Interventional Cutaneous T Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APR-TD011 (RLF-TD011).
Who it may be relevant to
Registry conditions: Cutaneous T Cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 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.

Primary outcome measures

  • Change in microbiome species [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dermatology CTU — Chicago

Identifiers

NCT: NCT05728879 · STU00217913

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗