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No participants were enrolled in the study.
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
| Rochester Skin Lymphoma Medical Group, PLLC | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3.75% Imiquimod Cream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to up to one year |
| Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events) |
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Inclusion Criteria:
Exclusion Criteria:
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Poligone, M.D. Ph.D. | Rochester General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32632956 | Derived | 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. |
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| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005447 | Fluocinonide |
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Open Label
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|
| 0.1% Fluocinonide Cream | Drug | 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. |
|
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We will record any adverse events that occur during the course of the study. |
| 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. | Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |