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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
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
Time frame: 16 weeks
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.
Time frame: 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.
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)
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.
Time frame: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)
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