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APR-TD011 Spray for Cutaneous T-Cell Lymphoma
Phase < 1
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial will study a new spray for treating skin lesions caused by a type of cancer. It will look at safety & how it affects the microbiome.
Who is the study for?
This trial is for adults with early-stage mycosis fungoides, a type of cutaneous T-cell lymphoma. Participants must have at least two skin lesions present for over three weeks and one lesion positive for staphylococcus aureus that doesn't need systemic antibiotics. They should not wash or apply anything to the lesion before visits and avoid antiseptic baths during the study.Check my eligibility
What is being tested?
The trial tests APR-TD011 (RLF-TD011) spray solution's effect on skin lesions caused by cutaneous T-cell lymphoma, specifically looking at how it changes the microbiome in these lesions and its tolerance when applied directly.See study design
What are the potential side effects?
While specific side effects are not listed, as this is an open-label pilot study focusing on tolerance, potential side effects may include local reactions like irritation or allergic responses where the spray is applied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in microbiome species
Trial Design
1Treatment groups
Experimental Treatment
Group I: CTCL participantsExperimental Treatment1 Intervention
Visits will include screening, pre-treatment (week 0), weeks 4 and 8.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,201 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on antibiotics recently or am currently taking them.I agree not to use bleach, vinegar baths, or antiseptics on the target lesion during the study.I have early-stage mycosis fungoides (stage IA or IB).I agree not to wash or apply anything to the lesion before my study visits.I have at least two large lesions that have been present for over 3 weeks.My infection is confirmed as staph but doesn't need strong antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: CTCL participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program open to new participants?
"As evidenced by clinicaltrials.gov, the recruiting period for this trial has ended. It was initially posted on February 1st and last modified on June 2nd 2023; despite that 1705 other studies are currently seeking participants."
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