Back to resultsCharacterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Primary Purpose
Cutaneous T Cell Lymphoma
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
APR-TD011 (RLF-TD011)
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T Cell Lymphoma
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.
Sites / Locations
- Dermatology CTU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CTCL participants
Arm Description
Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
Outcomes
Primary Outcome Measures
Change in microbiome species
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
Secondary Outcome Measures
Full Information
NCT ID
NCT05728879
First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05728879
Brief Title
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Official Title
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTCL participants
Arm Type
Experimental
Arm Description
Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
Intervention Type
Combination Product
Intervention Name(s)
APR-TD011 (RLF-TD011)
Other Intervention Name(s)
Nexodyn AOS
Intervention Description
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 Measure Information:
Title
Change in microbiome species
Description
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dermatology CTU
Phone
312-503-5944
Email
NUderm-research@northwestern.edu
Facility Information:
Facility Name
Dermatology CTU
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermatology CTU
Phone
312-503-5944
Email
NUderm-research@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Alan Zhou
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
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