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

Early Phase 1

Not yet recruiting

• Conditions: Cutaneous T Cell Lymphoma

• Registration Number: NCT05728879
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Study Start: 2025-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in microbiome species	4 weeks	Reduction of Staphylococcus aureus relative abundance between baseline and Week 4

Trial Locations

Locations (1)

Dermatology CTU; 🇺🇸 Chicago, Illinois, United States