Mycosis FungoidesCTCLNCT02301494
Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma
A study testing 3.75% Imiquimod Cream and 0.1% Fluocinonide Cream in people with Mycosis Fungoides, run by Rochester General Hospital.
Trial summary
This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- 3.75% Imiquimod Cream and 0.1% Fluocinonide Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male and female subjects aged ≥18 years.
- Willing and able to give informed consent
- Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes.
- Subjects must have at least one target lesion
- Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits.
- Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate method of contraception (abstinence, condoms, hormonal therapy, barrier methods) during the study.
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- Patients must be otherwise healthy with an ECOG Performance status of 0 or 1.
- The patient must not have had topical (2 weeks) or systemic therapy (4 weeks), radiotherapy (4 weeks) or phototherapy therapy (4 weeks) for Mycosis Fungoides within the stated number of weeks prior to start of treatment.
- Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids)
Who cannot join
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
- Received any investigational drug or taking part in any clinical study within one month prior to this study.
- Known reaction or allergy to test drug or excipient.
- Presence of major medical illness or symptoms of a clinically significant illness that may influence the study.
- Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol.
- Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.
About this study
Official title: Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma
This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).
Read the detailed description
The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.
- Conditions
- Mycosis Fungoides
- Being tested
- 3.75% Imiquimod Cream, 0.1% Fluocinonide Cream
- Keywords
- CTCL, Mycosis Fungoides, Cutaneous T-cell Lymphoma, MF, topical therapy, early stage
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.75% Imiquimod CreamDrug
Also called Zyclara 3.75%
CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.
0.1% Fluocinonide CreamDrug
Also called Vanos
CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Fluocinonide (Vanos) cream 0.1% | Experimental | Fluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow up at 6 and 12 months. Receives: Drug: 0.1% Fluocinonide Cream |
| 3.75% Imiquimod (Zyclara) Cream | Experimental | 3.75% Imiquimod (Zyclara) Cream will be used as currently labeled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow up at 6 and 12 months. Receives: Drug: 3.75% Imiquimod Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate between baseline and week 16
Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy
Measured: 16 weeks
Secondary outcomes (3)
Response Rate 24 and 52 weeks after baseline
Patients will be treated for 4 months and response rate assessed at 6 and 24 months after initiation of therapy.
Measured: Baseline to up to one year
Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)
We will record any adverse events that occur during the course of the study.
Measured: From Randomization to up to 30 days after end of treatment
Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies)
Using left over tissue from biopsies done at baseline, two weeks after initiation of therapy, and optional one done at week16. We are interested in making our tissue bank.
Measured: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startApr 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: No participants were enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc., Rochester Skin Lymphoma Medical Group, PLLC
- Responsible party
- Principal investigator, Brian Poligone, MD, PhD, Rochester General Hospital
- Investigators
- Brian Poligone, M.D. Ph.D., Principal investigator, Rochester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301494
- Sponsor's protocol ID
- 48861
- Acronym
- CTCL
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2014
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02301494
- Acronym / sponsor ID
- CTCL / 48861
- Conditions
- Mycosis Fungoides
- Keywords
- CTCL, Mycosis Fungoides, Cutaneous T-cell Lymphoma, MF, topical therapy, early stage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rochester General HospitalUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc., Rochester Skin Lymphoma Medical Group, PLLC
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- 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 study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).
Detailed description
The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluocinonide (Vanos) cream 0.1% | Experimental | Drug: 0.1% Fluocinonide CreamFluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow up at 6 and 12 months. |
| 3.75% Imiquimod (Zyclara) Cream | Experimental | Drug: 3.75% Imiquimod Cream3.75% Imiquimod (Zyclara) Cream will be used as currently labeled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow up at 6 and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects aged ≥18 years.
- Willing and able to give informed consent
- Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes.
- Subjects must have at least one target lesion
- Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits.
Key exclusion criteria (8 listed)
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
- Received any investigational drug or taking part in any clinical study within one month prior to this study.
- Known reaction or allergy to test drug or excipient.
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 |
|---|---|---|
| 3.75% Imiquimod CreamAlso: Zyclara 3.75%CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months. | Drug | 3.75% Imiquimod (Zyclara) Cream |
| 0.1% Fluocinonide CreamAlso: VanosCTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months. | Drug | Fluocinonide (Vanos) cream 0.1% |
Primary outcome
Response Rate between baseline and week 16
Time frame: 16 weeks
Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy
3 secondary outcomes
Response Rate 24 and 52 weeks after baseline
Time frame: Baseline to up to one year
Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)
Time frame: From Randomization to up to 30 days after end of treatment
Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies)
Time frame: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 32632956Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
- 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. This study is not recruiting at the moment.
Brian Poligone, M.D. Ph.D. principal investigator
Rochester General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3.75% Imiquimod Cream and 0.1% Fluocinonide Cream in people with Mycosis Fungoides, run by Rochester General Hospital.
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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate between baseline and week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301494, which also lists 1 linked publication.
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 27 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.