Cutaneous T Cell LymphomaEarly Phase 1NCT05728879
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
A Early Phase 1 study testing APR-TD011 (RLF-TD011) in people with Cutaneous T Cell Lymphoma, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- What is being tested?
- APR-TD011 (RLF-TD011)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dermatology CTU
Chicago, Illinois, 60611
Dermatology CTU, 312-503-5944, NUderm-research@northwestern.edu
Alan Zhou
About this study
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.
- Conditions
- Cutaneous T Cell Lymphoma
- Being tested
- APR-TD011 (RLF-TD011)
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APR-TD011 (RLF-TD011)Combination product
Also called Nexodyn AOS
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.
| Study group | Role | What they receive |
|---|---|---|
| CTCL participants | Experimental | Visits will include screening, pre-treatment (week 0), weeks 4 and 8. Receives: Combination Product: APR-TD011 (RLF-TD011) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome species
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong (Alan) Zhou, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728879
- Sponsor's protocol ID
- STU00217913
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray Solution
- ClinicalTrials.gov ID
- NCT05728879
- Acronym / sponsor ID
- STU00217913
- Conditions
- Cutaneous T Cell Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTCL participants | Experimental | Combination Product: APR-TD011 (RLF-TD011)Visits will include screening, pre-treatment (week 0), weeks 4 and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APR-TD011 (RLF-TD011)Also: Nexodyn AOSAPR-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. | Combination product | CTCL participants |
Primary outcome
Change in microbiome species
Time frame: 4 weeks
Reduction of Staphylococcus aureus relative abundance between baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing APR-TD011 (RLF-TD011) in people with Cutaneous T Cell Lymphoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dermatology CTU (312-503-5944, NUderm-research@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome species (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.