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

NCT ID: NCT05728879

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous T Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CTCL participants

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

Group Type EXPERIMENTAL

APR-TD011 (RLF-TD011)

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Nexodyn AOS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong (Alan) Zhou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dermatology CTU

Chicago, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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Dermatology CTU

Role: CONTACT

312-503-5944

Facility Contacts

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Dermatology CTU

Role: primary

312-503-5944

Other Identifiers

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STU00217913

Identifier Type: -

Identifier Source: org_study_id

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